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Abstract
Early initiation of lactation boosts infant health and immune system and allows
mothers to bond with their infant. This process may be delayed in new mothers whose
form to manage their pain. Current hospital protocol recommends prescribing oral
analgesia to post-Caesarean women on the second day after surgery however no fixed
1
guidelines or recommendations are in place in terms of type of oral analgesia
prescribed.
This cohort study aims to determine if there are significant differences in terms of time
to first initiate unassisted lactation between mothers who receive Mefenamic acid,
the breast directly for the first time after birth, supported only by the mother and
without assistance”. 121 post-Caesarean women were recruited into this study, who
received either Mefenamic acid, Celecoxib or Tramadol within the first 12 hours post-
surgery. They are then interviewed regarding the time taken to first initiate unassisted
lactation.
The results of the study showed that all three medications were similar in terms of
time taken by new mothers to initiate unassisted lactation. The choice of oral
medications did not significantly alter the time taken to first initiate unassisted
1.0 Introduction
emotional bonding between infant and mother, helps keep the baby warm, and reduces
in the neonatal period, also plays an important role in reducing infant mortality[2]. It is
with these concerns in mind that it is pertinent to find the most effective pain
2
Initiation of lactation is most successful when a mother is physically and
is important to allow the mother to be alert and energetic enough to be able to provide
care to their infant and to breastfeed their infant[3]. In 2009, Khan et all found that
post-operative analgesia ensured that patients were pain-free and enabled early
Breastfeeding Medicine Clinical Protocol #15: Analgesia and Anesthesia for the
improving mobility, early recovery and the need for supplemental analgesia [3,6,7].
Caesarean section because it may impair the recovery process as well as affect the
mothers’ ability to care for her infant[3]. Administering analgesia to new mothers
reduces the pain from the surgical scar and also facilitates early recovery[8]. Post-
partum pain that is not managed properly can inhibit the ability of new mothers to
initiate early lactation.[4-6], thus allowing new mothers to start nursing their newborn
Mersky in 1986 defined pain as “an unpleasant sensory and emotional experience
Taverner[10] in 2005 as well as Bendelow[11] in 2008 have shown that pain differs
3
towards pain, and perception of pain can be affected by gender, emotional well-being,
In this cohort study, we aim to compare the efficacy of different analgesics in the
every 6 hours for the first 24 hours, followed by an oral analgesia on day 2, to be
continued until patient is discharged. Three oral analgesics are compared in this cohort
The mechanisms of pain can generally be divided into central and peripheral pain.
Peripheral pain arises from surgical trauma or a noxious stimulus that stimulates the
may have two components; pain that arises from the wound itself (somatic pain) and
pain arising from the uterus (visceral pain). Sensitization that occurs in the central
neurogenic pain[12].
NSAIDs alleviate mild to moderate peripheral pain. They work primarily by inhibiting
4
prostaglandins from arachidonic acid. Prostaglandins are mediators of inflammation,
peripheral sensation of pain. Both Mefenamic acid and Celecoxib reversibly inhibit the
normal physiologic functions in the gastrointestinal tract, kidneys and platelets while
perforation, renal side effects such as sodium and water retention and/or
bleeding time[6], which may be a problem in women who undergo Caesarean section.
NSAIDs however has an advantage over opioids as they are associated with narcotic
vomiting, reduced sedation and there are also suggestions that NSAIDs may improve
5
Celecoxib is a relatively new non-steroidal anti-inflammatory drug that selectively
pain, but without the gastrointestinal side effects, renal side effects, platelet
Mefenamic acid, therefore it may be a more suitable choice for management of post-
Caesarean section as it provides pain relief to new mothers with only minimal side
maternal bleeding is a concern, but this must be balanced with higher costs and
derives its central activity due to an analgesic binary mechanism of action. Tramadol
acts as an agonist and binds to µ-opioid receptors that suppress the release of
noradrenaline and serotonin to interfere with central pathways that mediate pain[17].
Tramadol has proven efficacy in the management of chronic pain as well as post-
operative pain[18] but it has a number of documented side effects such as pain,
pruritus, nausea, vomiting, sedation and respiratory depression that can affect patients
recovery[3,14].
such an important facet of physical health that it is sometimes referred to as the fifth
The aim of post-operative pain management is to minimize and alleviate pain with the
least side effects, to provide patient comfort and satisfaction and to allow early
mobilization. Pain that is properly managed also reduces the occurrence of further
management also reduces the cost of care and reduces morbidity and mortality[12,20].
Pain that is effectively managed is also linked to fewer incidences of pulmonary and
This cohort study aims to compare the breastfeeding outcomes of various approaches
subsequently determine which of the two NSAIDs involved in this cohort study
provides better pain relief and allows new mothers to initiate lactation sooner.
Both opioids and NSAIDs provide pain relief post-surgically[21], however currently
there are no fixed guidelines regarding the use of oral analgesia in managing post-
Caesarean pain. Opioids are effective in alleviating central pain and Tramadol is an
section pain. It is centrally acting and has proven efficacy in the management of
NSAIDs, on the other hand, provide excellent analgesia for mild to moderate
peripheral pain. Oral non-narcotic agents such as ibuprofen are able to provide
satisfactory pain relief for post-Caesarean section pain[7], and this cohort study aims
to determine if other NSAIDs may also have the same effect in relieving post-
NSAIDs are more cost effective, have less sedative effects and produces less side
effects such as emesis[22] compared to narcotic agents. Patients who receive NSAIDs
also have fewer concerns over dependency and drug seeking behavior[21] which may
be an issue when patients are administered opioids such as Tramadol. Opioids provide
superior pain relief in terms of central pain but its use may be limited by patient
concerns over dependency as well as the high incidence of side effects associated with
its use. The sedative effects of opioids also impair patient recovery and delay the
8
similar or more efficacious analgesia in post-Caesarean pain compared to opioids in
Finally it is hoped that the outcomes of this cohort study can benefit healthcare
practitioners and new mothers in choosing a more suitable and effective oral pain
management regimen for women after Caesarean section that will provide optimum
pain relief as well as allow new mothers to begin initiating lactation sooner.
patients experienced acute pain and received inadequate pain management after
abdominal hysterectomy[23]. This result suggests that the regimen for management of
pain that is currently employed is still not sufficiently able to alleviate pain especially
in post-surgical settings, and can still be improved in order to provide patient comfort
Health and Human Services, issued guidelines in 1992 concerning, Acute Pain
recognized that pain management practices currently adopted in hospitals are still
generally inadequate. The AHCPR also noted that post-operative pain that is not
should be looked into to address these problems to benefit both the patient and the
healthcare institutions.
Pan PH, in the International Journal of Obstetric Anaesthesia in 2006 stated that
proper pain management reduces the need for supplemental analgesia 24-hours post
surgery and reduces the risks for complications post-surgery such as the development
receive efficient pain management to be able to recover quickly from surgery and to
In 2000, Jakobi et al carried out a three month study on 199 women who underwent
Caesarean section. The women were divided into two groups, who both received an
NSAID and an opioid, but with differing regimens. The results of the study showed
modalities used for management of pain. The results also showed that post-Caesarean
section women whose pain has been effectively managed were able to recover earlier
from surgery[7].
enabled the mother to optimally care for her infant in the immediate post-partum
period[6]. Gadsden also found that pain can impair a mother’s ability to breastfeed
effectively especially in the post-partum period[6]. This clearly shows the benefits of
deliveries.
Pan PH et al concluded that proper pain management reduces the need for
supplemental analgesia and reduces the risk for post-surgical complications. Pan PH
reduce the risk for thromboembolic events, which may also be precipitated by
immobility from inadequate pain control[3]. Apart from that, it is imperative that new
alert and energetic enough to care for, interact with and breastfeed their newborn
infant[3].
11
Gadsden et al in 2005 stated that pain and anxiety that were not addressed and treated
properly may reduce the ability of new mothers to breastfeed effectively in the
immediate post-partum period[6]. It is therefore clear that there is a need for effective
Montgomery et al in 2006 stated that proper analgesia and anaesthesia for post-partum
spontaneous vaginal births (SVD) without administration of epidurals had the highest
operative pain is not managed adequately[5]. Post-Caesarean pain that is not managed
properly may affect the initiation of breastfeeding and may adversely affect
breastfeeding outcomes.
that 38.7% of the patients were pain free, 19.4% of the patients were able to achieve
In 1999 Clemens et al found evidence that showed early initiation of lactation could
reduce the incidence if infantile diarrhoea. Out of the 198 infants in rural Egypt who
were recruited, 151 infants (76%) began breastfeeding within the first 3 days of life.
12
Clemens found that initiation of breastfeeding shortly after delivery benefited the
infant in terms of reducing the occurrence of diarrhoea throughout the first 6 months
of life (26% lower rate of diarrhoea compared to infants who began breastfeeding later
the health of the infants and enhanced the protective effect of breastfeeding against
diarrhoea compared to infants who began breastfeeding later. During the first few days
after birth, the mother’s body produces colostrum which has immune properties and is
Edmond et al in 2006 also found evidence that showed early initiation of lactation
could reduce the risk of neonatal mortality. Edmond et al followed up on 10947 babies
in rural Ghana. He found that early initiation of breastfeeding (within the first hour)
within the first day could reduce neonatal mortality by as much as 16%[26]. These
results clearly show the benefits that could be obtained if initiation of lactation began
Hale et al in 2004 carried out a study on 2 mothers regarding the transfer of Celecoxib
into breastmilk. The 2 mothers had been on Celecoxib for many weeks, and the levels
of Celecoxib in maternal plasma were already at steady-state. Milk was pumped from
the breast and was analysed to determine the levels of Celecoxib found in maternal
milk. Results showed that the relative infant dose of Celecoxib found in maternal milk
is very low (0.3% of maternal dose) and the safety profile of Celecoxib is generally
13
high[27]. This is further strengthened by the fact that the 2 infants who were breastfed
by the women recruited into this study did not show any untoward effects.
In 2005, Gardiner carried out a study in New Zealand to quantify infant exposure to
Celecoxib through breast milk. Six women were placed on 200mg Celecoxib od. Milk
was pumped out of the breast and analysed. The concentrations of Celecoxib found in
the breast milk were low (0.2% of maternal dose). Gardiner concluded that given the
low transfer of Celecoxib into milk, breastfeeding during routine dosing would pose
Previous research has shown that individual NSAIDs do differ in their analgesic
currently not being prescribed in local settings for management of post-surgical pain in
post-Caesarean women. However, data obtained from the Oxford League Table of
Analgesic Efficacy gives us reason to believe that Celecoxib may be more effective in
alleviating pain compared to Tramadol due to the difference in the number needed to
Analgesic Efficacy which compares the relative efficacy of numerous NSAIDs and
opioids in the management of pain[29]. In this cohort study, Celecoxib 200mg bd and
Tramadol 50mg tds are included. According to the Oxford League Table of Analgesic
Efficacy, Celecoxib 200mg has a NNT of 3.5, while Tramadol 50mg has a NNT of
14
8.3[28]. NNT values for Mefenamic acid are not included in the Oxford League Table
of Analgesic Efficacy.
These NNT values correspond to the number of patients needed to treat for one patient
to report at least 50% pain relief over 4-6 hours compared with placebo. A drug that
has a lower NNT is more effective in alleviating pain compared to a drug with a higher
NNT. The table suggests that Celecoxib 200mg provides superior pain relief in
patients with moderate to severe pain compared with Tramadol 50mg, as well as
providing pain relief without the side effects associated with opioid use. With this in
Caesarean deliveries.
However, it must be noted that the data obtained from the Oxford League Table is
well as experiencing different types of pain due to different causes. It is important for
us to realize that a certain drug that is well-suited to one type of pain setting may have
obtained from the Oxford League Table cannot be used as a specific guide concerning
the relative efficacy of analgesics in managing post-Caesarean section pain since the
table does not mention the specific indications for the use of the analgesics
included[29].
15
This means that there still remains a need for further studies to determine which
Opioid analgesics have been shown to provide adequate pain relief in post-surgical
settings[7,18] but the number of documented side effects such as pain, pruritus,
nausea, vomiting, sedation and respiratory depression can affect the patients recovery
[3,14], subsequently limiting their use in post-surgical setting. NSAIDs on the other
hand were associated with narcotic sparing effects such as improved respiratory
function, reduction in nausea and vomiting, reduced sedation and there is a suggestion
that NSAIDs may improve not only the quality but also the speed of recovery[16].
hip arthroplasty, upper and lower abdominal surgery and minor outpatient surgery[16].
A randomized control trial carried out by Reuben et al in 2005 showed that COX-2
inhibitors were effective in improving recovery and restoring function to patients after
total knee arthroplasty as well as reducing opioids consumption and their related side
In a survey carried out by Warfield et al in 1995 in the United States, 71% of the
respondents reported that they would prefer a non-opioid to an opioid analgesic after
16
surgery[30]. The survey did not specify the respondent’s concerns regarding the use of
opioids for pain management after surgery, but Warfield speculated that respondents
may be concerned about the side effects related to opioid use, as well as the risk of
NSAIDs can work as well as or even better in offering pain relief compared to opioids
Tramadol.
17
1.6 Research Objectives
lactation.
This cohort study was conducted at the obstetric wards for a period of 2 months .
All patients who were admitted into the obstetric wards for elective and emergency
Caesarean section were recruited for this cohort study. However, an inclusion and
18
exclusion criteria was developed so that the targeted group may be specified more
Inclusion criteria
Exclusion criteria
Sample size
The number of patients to be recruited for this cohort study is 278, based on an
estimated population of 1500 women who undergo Caesarean section at the obstetric
wards. The number of patients (278) was calculated using Power and Precision V3,
which gives us a confidence level of 95% and confidence interval of +/- 5%.
It is therefore proposed that the number of patients required for each group will be 90.
Patients on Mefenamic Acid 500mg tds are placed in group A, patients on Celecoxib
200mg bd in group B and patients on Tramadol 50mg tds are placed in group C, the
control group.
19
However, at the end of 2 months the number of patients recruited was only 165.
2.2 Methodology
Women who underwent Caesarean deliveries were recruited for this cohort study.
Where possible, patient consent was taken before patients underwent surgery. This
group of patients typically comprised of women who opted for elective Caesarean
sections and were admitted into the ward the day before elective Caesarean delivery.
However, consent before surgery was not able to be obtained from patients who
underwent emergency Caesarean section. In these cases, consent was obtained once
the patient returned to the ward after surgery, but before administration of oral
analgesia.
20
All of the patients recruited for this cohort study received complete explanations of the
study, including the importance of the study, its benefits to the patient and future
patients, as well as any risks they may face during the study. Patients were also
encouraged to voice out any concerns or questions regarding the cohort study. Each of
the patients also gave written consent to the researchers after receiving information
Post-surgery, patients are placed on oral pain medications as indicated by their doctor.
The researchers were not involved in determining the type of medication a patient was
given. Patients who were given Mefenamic acid 500mg tds, Celecoxib 200mg bd or
Patients were served oral medications within 12 hours post-surgery and continued
receiving medication until they were discharged from the hospital, which is usually on
the 2nd day post-surgery. Patients will also be concurrently placed on parenteral
analgesia (IM pethidine), which is administered to the patient every 6-hourly for the
first 24 hours post surgery, as per current hospital department policy for post-operative
will only receive oral pain medication. Patients may request for additional analgesia if
necessary. Patient’s request for additional analgesia will be noted down, and the
number of times they request for analgesia will also be noted down.
duration of surgery is recorded. The researcher will also record the type of oral
analgesia received and time of first administration of analgesia (for example, 3 hours
post-surgery). Patients’ request for extra analgesia will also be noted down, if any.
After oral medication is served, the patient will be interviewed regarding the time
taken for the patient to first initiate unassisted lactation. The first initiation of
unassisted lactation is defined as “the baby suckling at the breast directly for the first
time after birth, supported only by the mother and without assistance”.
The time to first initiate unassisted lactation is obtained through patient self-reporting
to the researcher. The time will be recorded in hours. The patient will also be
questioned on any problems faced during lactation, for example poor milk production,
inability to hold the infant in the right position, breast engorgement, plugged milk duct
etc.
All the data collected were transcribed into the SPSS version 17 software programme.
Basic descriptive statistics were used to outline the demographic variables. In simple
two-group comparisons, the Student t-test was used to determine the association
assumptions were not fulfilled, Mann-Whitney test was used for simple two-group
comparisons.
22
For three-way comparisons between dependent and indepenedent demographic
parametric assumptions were not fulfilled). The level of significance, α is set at 0.05
(α=0.05)
3.0 Results
In the 2 months cohort study, 165 women undergoing Caesarean delivery were
recruited, ranging from 20 years of age to 40. 98 of the subjects were Malay, 24 were
Chinese, 34 were Indian, and 9 of the subjects were foreigners. 69 patients received
Mefenamic Acid 500 tds, 23 patients received Celecoxib 200mg bd and 73 patients
Of the 165 women recruited, only 121 subjects were able to give information
regarding time of first initiation of unassisted lactation. 44 subjects were not included
in this study as they were not able to give information applicable for this cohort study.
41 subjects had their infant admitted into the ICU, while a further 3 infants passed
away during delivery or after delivery, therefore they were excluded from this cohort
study.
23
Out of the 121 subjects included in the study, 50 subjects were served Mefenamic
24
Figure 6 Graph of distribution of number of hours taken to initiate unassisted lactation post-
surgery
The mean time to initiate lactation is 16.17 hours, while the median time to initiate
3.3 Difference in the time taken to initiate unassisted lactation between NSAIDs
and Tramadol.
The mean time taken initiate lactation is shorter in patients who receive Tramadol
25
A test of normality is carried out using Kolmogorov-Smirnov test. The p-value for
Tramadol is 0.02, which is lower than 0.05, therefore the data obtained for this study is
Kolmogorov-Smirnova Shapiro-Wilk
DrugType Statistic df Sig. Statistic df Sig.
BreastFeed Mefenamic Acid .139 50 .018 .960 50 .091
Celecoxib .113 19 .200* .959 19 .562
Tramadol .161 52 .002 .901 52 .000
Since the data is not normally distributed, we cannot use parametric tests such as t-test,
therefore to test if this difference in time taken to initiate lactation is significant a non-
Table 4: Mann Whitney test on time to initiate lactation between NSAIDs and Tramadol.
BreastFeed
Mann-Whitney U 1633.000
Wilcoxon W 3011.000
Z -.844
Asymp. Sig. (2-tailed) .399
The null hypothesis (H0) for the Mann-Whitney test is there is no difference in the
time taken by mothers to first initiate unassisted lactation between NSAIDS and
Tramadol, while the alternate hypothesis (H1) is there is a significant difference in the
time taken by mothers to first initiate unassisted lactation between NSAIDS and
Tramadol.
26
The results of the Mann-Whitney test returned a p-value of 0.399, which is greater
than the level of significance of 0.05. The results suggest that there is statistically no
significant difference between the time to initiate lactation between NSAIDs and
The time taken to first initiate unassisted lactation for patients on Mefenamic acid was
16.82 hours, Celecoxib was 15.79 hours and Tramadol was 15.69 hours.
The data obtained is not normally distributed; therefore statistical analysis such as one-
way analysis of variance (ANOVA) cannot be used. Instead, Kruskal-Wallis test was
carried out to test if there is a significant difference in the number of hours taken by
mothers to first initiate unassisted lactation between Mefenamic acid, Celecoxib and
Tramadol.
The null hypothesis (H0) is there is no significant difference in the time taken for
mothers to first initiate unassisted lactation between Mefenamic acid, Celecoxib and
27
Tramadol. The alternate hypothesis (H1) is there is a significant difference in the time
taken for mothers to first initiate unassisted lactation between Mefenamic acid,
Table 5: Kruskal-Wallis test result of time taken to first initiate lactation between Mefenamic
BreastFeed
Chi-Square .812
df 2
Asymp. Sig. .666
The probability of the Kruskal-Wallis statistic is 0.666, which is greater than the level
of significance of 0.05. We fail to reject the null hypothesis and conclude that the
first initiate lactation between Mefenamic acid, Celecoxib and Tramadol (p = 0.666)
3.5 Difference in the time taken to initiate unassisted lactation between races
The mean time taken to first initiate unassisted lactation in Malay women was 15.49
hours, in Chinese women 17.07 hours, 17.93 hours in Indian women and 14.50 hours
28
Since the data obtained is not normally distributed, a Kruskal-Wallis test was carried
out to see if there is a difference in the time taken to initiate unassisted lactation
The null hypothesis (H0) of the test is there is no significant difference in the time
taken to first initiate unassisted lactation between races while the alternate hypothesis
(H1) is there is significant difference in the time taken to first initiate unassisted
The probability of the Kruskal-Wallis test obtained is 0.491, which is greater than the
level of significance of 0.05. There is no significant difference in the time taken to first
Table 7:Kruskal-Wallis test on time to initiate lactation between women of different races.
BreastFeed
Chi-Square 2.412
df 3
Asymp. Sig. .491
29
3.6 Difference in the time taken to initiate unassisted lactation between mothers
Women who opted for elective Caesarean deliveries took a mean time of 14.49 hours
to first initiate unassisted lactation compared with a mean time of 17.49 hours to first
taken to first initiate unassisted lactation between women who underwent elective or
The null hypothesis (H0) for the Mann-Whitney test is there is no difference in the
time taken by mothers to first initiate unassisted lactation between elective and
significant difference in the time taken by mothers to first initiate unassisted lactation
The results of the Mann-Whitney test returned a p-value of 0.080, which is greater
than the level of significance of 0.05. The results suggest that there is statistically no
significant difference between the time to initiate lactation between elective and
Table 8: Mann-Whitney test on time to initiate lactation between elective and emergency
Caesarean procedures.
30
BreastFeed
Mann-Whitney U 1467.000
Wilcoxon W 2898.000
Z -1.753
Asymp. Sig. (2-tailed) .080
4.0 Discussion
4.1 Comparison on time to first initiate unassisted lactation between NSAIDs and
Tramadol
31
Mothers who experience pain may find it hard to initiate lactation on their own
without assistance, because the process of carrying their infant and placing them
against the breast to breastfeed requires effort and strength. Mothers whose post-
operative pain is not managed properly may not be strong enough to be able to lift
their infant to breastfeed them on their own. It is therefore significant to interview the
mothers regarding their ability to breastfeed their infant on their own and when they
are able to first begin initiation of lactation as we can correlate the results with the
The results of the statistical analysis indicate that there is no difference in the number
of hours taken to first initiate unassisted lactation between all three drug types, as well
as between drug classes. This means that mothers first began breastfeeding their infant
on their own at around the same time between the two drug classes, therefore we infer
The use of opioids typically produce more sedative effects in new mothers, and can
However, results of this study showed no difference in time taken to first initiate
unassisted lactation in mothers who received oral opioids and mothers who received
The results of this cohort study was in accordance with Chang et al in 2005, who
epidural analgesia[31]
analgesics did not significantly improve the time taken for mothers to first begin
breastfeeding their infants on their own. The difference in the time taken to initiate
lactation is minimal, and may not warrant the need for hospital protocol to be amended
to include Celecoxib.
different races.
differently. Specifically, African Americans were more sensitive to pain, which shows
The women recruited for this cohort study comprised of Malays, Chinese, Indians and
a small group of foreign women who were categorized as ‘Other’ races. In a study
33
conducted by Tan et al in 2008 on 1034 women who underwent elective lower
Caesarean section (LSCS), it was found that ethnic Indian patients reported higher
pain and used more morphine compared to Chinese or Malays[32]. This difference in
perception of pain between different races could affect the time to initiate unassisted
Analgesia and Anesthesia for the Breastfeeding Mother clearly states that post-partum
breastfeeding[5].
In this cohort study however, results of the Kruskal-Wallis test on difference in time to
first initiate unassisted lactation between races did not reveal any significant findings.
There is no significant difference in the time taken to first initiate unassisted lactation
between mothers of different races (p = 0.491), which we can interpret as all post-
Caesarean women received adequate analgesia after delivery or that there were no
4.4 Comparison on time to first initiate unassisted lactation between women who
typically have complicated births which can lead to stress both during and after the
34
event, and 13 out of the women experienced various forms of post-traumatic stress
and mentally prepared for breastfeeding, which can lead to problems in initiation of
Apart from that, a study carried out by Hillan et al in 1995 found that women who
operative morbidity assocated with Caesarean section compared to women who opted
in 1984 on 1319 women, he found that the rate of complications associated with
emergency Caesarean section was 18.9% compared to only 4.2% for elective
pain levels and experience longer recovery duration. These factors could affect the
The results of statistical analysis showed no significant difference between the time to
Women undergoing Caesarean section in this cohort study began to first initiate
unassisted lactation at around the same time regardless of type of surgical procedure
importance in this cohort study as it can affect the result outcomes in terms of time
delivery pain as minimal it is highly likely that the patient will be able to regain
strength and function sooner and be able to recover earlier. Patients who have a low
tolerance to pain and have a high perception of post-Caesarean delivery pain will not
be able to fully regain function and recover as quickly, which may then delay the time
Patients who have a higher perception of post-Caesarean delivery pain may require
and receive additional analgesia which could affect patient function as well as lead to a
higher occurrence of side effects compared to patients who do not request or receive
additional analgesia. The side effects associated with the extra analgesia could affect
well-being, age, race, gender, culture, religion as well as past experience[9-11]. It also
must be noted that pain in ambulatory and resting conditions may differ, as was
reported by several subjects involved in this study. Several subjects felt that
ambulatory pain was worse compared to pain at rest, and this could be due to the fact
that movement and ambulation aggravated the surgical scar, therefore causing more
36
Regardless of the difference in perceptions of pain in difference individuals, it is
accepted that patients who undergo surgeries will experience some form of pain.
Women who undergo surgical procedures during delivery, for example Caesarean
deliveries, will be placed on analgesia to manage the pain both during and after
surgery.
The initial methodology was to serve pain medication to the subjects within 6 hours,
but this was not readily adhered to due to lack of manpower and lack of cooperation
by the hospital staff. The research methodology was then amended to include patients
who were served medication within 12 hours. The long duration before patients were
lactation before medication was served. This is because the number of hours to initiate
lactation is calculated from the time the first dose is administered to the patient and not
from time the patient returns to the ward after surgery ends.
Apart from that, Celecoxib is a specialist medicine, and is not readily available in the
maternal wards. Patients who were placed on Celecoxib needed to have their
prescription signed by a specialist, which then had to be filled out at the inpatient
pharmacy department prior to the medication being sent to the wards and subsequently
served to the patients. This process was lengthy and several patients placed on
Celecoxib had to be excluded from this study because they were served medication
37
outside of the time-frame specified for this cohort study (more than 12 hours post-
surgery).
At least 278 patients were supposed to be recruited for this cohort study, but the final
sample size was only 165, whereby only 121 were included in the study. The
possibility of extending the study was not made available, therefore the study had to be
concluded with only 121 patients who fit all the criteria necessary for this cohort
study.
The lack of subjects can be due to the fact that many patients had limited access to
their infants. 44 women who consented to this study had their infants admitted into the
ICU, which prevented them from having full access to their infant. This led to the
women not being included in the study, as some had their infants placed in ICU until
they were discharged. Also, most of the infants who were admitted into ICU were
placed in incubators, thereby interfering with the mothers ability to initiate unassisted
lactation, as they were not able to carry their infant and cradle them in their arms to
breastfeed them.
3 infants whose mothers had consented to this study also passed away due to poor
infant health and poor prognosis. The infant deaths were not caused by the protocols in
this cohort study, as the medications involved in this cohort study were not
38
administered to the patients prior to birth. These three mothers had to be excluded
The small number of subjects given Celecoxib (23 patients out of 165) is also a
limiting factor in this cohort study, because the small sample size does not allow us to
properly analyse the effects and efficacy of Celecoxib in post-Caesarean setting. The
fact that the number of patients in each group (Group A-Mefenamic acid, Group B-
Celecoxib and Group C-Tramadol) were not equal can be attributed to the fact that this
study is a cohort study, and it is difficult to equalize the sample size for each group,
since the patients are placed on oral medications based on doctors’ preference. The
researchers are not involved in the decision to administer which oral analgesia the
patient is to be given.
The small number of patients placed on Celecoxib may also be due to the reluctance of
the doctors in the wards to place their patients on Celecoxib due to cost and safety
concerns. Also, the prescription for Celecoxib had to be signed by the specialist and
sometimes this was not performed in due time which resulted in patients not being
given Celecoxib.
Patients also had to be excluded from the study if they did not receive medication in a
timely fashion. Several patients did not receive medication promptly (within 12 hours
post-surgery) while several patients did receive medication within the 12-hour time
frame but their subsequent second or third dose was not given on time or was missed.
This caused us to exclude these patients, as the data obtained from them may be
inaccurate.
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4.6.3 Data over or underestimated
The data on time taken to first initiate unassisted lactation was obtained from the
patient through patient self-reporting to the researcher. The researcher was not present
at the bedside of the patients at all time to observe and note down the exact time of
initiation of unassisted lactation. The data obtained relied on patients memory, which
may be fuzzy and inaccurate, and which may be affected by their pain levels as well as
that the data obtained may be over or underestimated, for instance patients report
but in actuality it may be earlier or later. This will affect the results of the study, and
must therefore be considered when carrying out studies that rely on patient self-
pain medication
The women who underwent Caesarean section were also concurrently placed on
several other medications. This cohort study did not take into consideration other
could adversely affect the initiation of unassisted lactation. Different medication may
cause maternal side effects that could delay the initiation of unassisted lactation or
may cause lactational problems such as lack of milk, plugged milk ducts etc. Current
medical conditions were also not taken into consideration in terms of its effects on
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4.6.5 Risk of type II error due to small sample size
The expected sample size for this cohort study was 278; however at the end of the
cohort study, the number of subjects recruited was only 121. The p-value obtained in
lactation between emergency or elective Caesarean section was 0.080. This value is
only slightly above the significant value of α=0.05. This shows that there may be a
section, however the limited sample size could lead to a type-II error in which a false
In order to ensure type-II errors do not occur, further studies involving a larger sample
size can be carried out to determine if there is significant difference in time to initiate
section. The results could be beneficial in terms of investigating the causes for this
5.0 Conclusion
Patients who received Mefenamic acid, Celecoxib and Tramadol began to initiate
unassisted lactation at the same time, regardless of race or type of operative procedure.
New mothers were able to regain function and recover well for unassisted
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The research hypothesis proposed in this cohort study where patients on Celecoxib
would initiate unassisted lactation sooner compared to Mefenamic acid and Tramadol
Mefenamic acid and Tramadol provided the same analgesic efficacy compared to
Celecoxib. The results of this cohort study did not warrant a need to change current
analgesia to new mothers. The results did not show an improved time to initiate
both opioid and non-opioid analgesia (multimodal analgesia) which would address
Women who are primiparous (women having their first child) and multiparous (who
who have previously given birth) may have different perceptions of pain, which could
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affect the time taken to first initiate unassisted lactation. Further research should be
carried out to assess the post-Caesarean outcomes in these two groups of women.
post-operative analgesia. This can be achieved by extending the duration of the study,
which can also allow the researcher to obtain a larger sample size, which will further
regime that is most cost effective to the healthcare institute as well as patients. The
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