Acta Anaesthesiol Scand 2012; ••: ••–••
Printed in Singapore. All rights reserved
Diclofenac–tramadol vs. diclofenac–acetaminophen
combinations for pain relief after caesarean section
S. Mitra1, P. Khandelwal1 and A. Sehgal2
1
Department of Anaesthesia & Intensive Care, Government Medical College & Hospital, Chandigarh, India and 2Department of Obstetrics &
Gynaecology, Government Medical College & Hospital, Chandigarh, India
Background: We compared the analgesic efficacy of
diclofenac–acetaminophen combination with diclofenac–
tramadol combination to optimize multimodal post-operative
analgesia in women undergoing caesarean section.
Methods: In this randomized, double-blind, parallel-group
controlled trial, 204 women undergoing caesarean section under
spinal anaesthesia with bupivacaine received rectal suppository
diclofenac 100 mg (8 hourly till 24 h) plus either intravenous
acetaminophen (1 g 6 hourly) or tramadol (75 mg 6 hourly) post-
operatively. The primary outcome measure was the summed
pain intensities during the entire observation period, calculated
as the sum of time-weighted pain intensity scores as an area
under the curve (AUC). Secondary outcome was the use of
rescue analgesic, administered if the patient’s numeric rating
scale (NRS) scores ⱖ 4.
Results: The overall pain score for the entire observation
period measured as AUC was significantly lower in the
diclofenac–tramadol group. However, diclofenac–tramadol
combination produced Bonferroni-corrected statistically signifi-
cant lower NRS pain scores only on movement at 24 h. Rescue
A dequate pain relief following caesarean
section in women using a safe but effective
analgesic combination is a universal concern,
because pain relief is a fundamental human right.1
Although multimodal analgesic combinations are
well accepted, finding the right combination of anal-
gesics remains the key question, where safety of the
mother and of the newborn baby (due to passage of
the drug in breast milk) is not jeopardized while
providing effective analgesia. A large number of
women undergo caesarean section at our hospital;
hence, their effective pain relief as well as safety is of
paramount importance.
The currently used combination in our hospital
for this purpose (diclofenac–tramadol), while
usually considered effective, does raise issues about
tolerability and adverse effects, both for the mother
and for the baby. This is because while tramadol is a
© 2012 The Authors
Acta Anaesthesiologica Scandinavica
© 2012 The Acta Anaesthesiologica Scandinavica Foundation
ACTA ANAESTHESIOLOGICA SCANDINAVICA
doi: 10.1111/j.1399-6576.2012.02663.x
analgesic consumption was comparable between the groups
(13% vs. 12%, P = 0.872). Overall, the pain scores were low
in both of the groups across various time intervals (median
NRS scores 0–2 for pain both at rest and on movement), indi-
cating satisfactory pain control in both groups. Side effects
were few and comparable, except nausea (significantly more
in tramadol group than acetaminophen group, 15% vs. 2%,
P = 0.001).
Conclusion: Both diclofenac–tramadol and diclofenac–
acetaminophen combinations can achieve satisfactory post-
operative pain control in women undergoing caesarean section.
The diclofenac–tramadol combination was overall more effica-
cious but associated with higher incidence of post-operative
nausea.
Accepted for publication 19 January 2012
© 2012 The Authors
Acta Anaesthesiologica Scandinavica
© 2012 The Acta Anaesthesiologica Scandinavica Foundation
centrally acting weak opioid receptor agonist along
with monoamine neurotransmitter reuptake inhibi-
tor property, it has all the known adverse effects of
an opioid. The adverse effects can indeed be trou-
blesome, not only with the common opioid side
effects like nausea, constipation and itching, but also
the rare but potentially fatal serotonin syndrome.
Injectable acetaminophen (paracetamol) is a safer
and cheaper option, but its analgesic efficacy is often
unclear in this scenario especially when used as a
stand-alone analgesic. Reports of combination of
injectable acetaminophen with diclofenac or other
non-steroidal anti-inflammatory drugs (NSAIDs)
are encouraging in experimental acute pain2 and
various operative settings,3–7 but these combinations
have not been tried in the case of women undergo-
ing caesarean section. NSAIDs exert their action by
inhibiting prostaglandin synthesis via inhibition of
1
S. Mitra et al.
cyclooxygenase, and the main mechanism of action
of acetaminophen, while not completely under-
stood, may also involve a similar mechanism at a
central level. If found to be equivalently effective
compared with the currently practiced standard in
our hospital (i.e., diclofenac–tramadol combination),
the superior tolerability profile of the diclofenac–
acetaminophen combination could be an asset
in this specific perioperative setting. Finally,
the diclofenac–acetaminophen combination, being
cheaper than the standard combination, could prove
to be a cost-efficient solution to the problem if found
equivalent to the standard combination.
Thus, the aim of this study was to compare the
analgesic efficacy of diclofenac–acetaminophen
combination with the currently used diclofenac–
tramadol combination in women undergoing cae-
sarean section in a large teaching hospital in India in
order to study whether opioids (tramadol) can be
replaced by acetaminophen in parturient women.
This study also compared the side-effect profiles
of diclofenac–acetaminophen combination with the
currently used diclofenac–tramadol combination in
the study groups. The specific hypothesis was that
the diclofenac–acetaminophen combination would
not be significantly different from the diclofenac–
tramadol combination in this population as regards
analgesic efficacy, whereas the adverse effects
would be less with the former.
Methods
This was a randomized, double-blind, parallel-
group controlled trial. Approval was obtained
from the Institute Ethics Committee, and informed
consent was obtained from the study participants.
Data collection took place from March 2008 and was
completed in March 2009.
The inclusion criteria were: women aged 18–35
years, American Society of Anesthesiologists (ASA)
status I and II, undergoing caesarean section. The
exclusion criteria were: ASA status ⱖ III; major
co-existing medical illness such as severe asthma,
uncontrolled hypertension or diabetes, liver
disease; peptic ulcer disease or gastrointestinal
bleeding; severe pregnancy-induced hyperten-
sion; already on long-term analgesics; at-risk fetus;
and known hypersensitivity to any of the study
medications.
The patients meeting the inclusion criteria earlier,
and those providing written informed consent
were randomized for the study using computer-
generated random table numbers, and the allotment
2
was done using coded sealed opaque envelopes.
Participants were enrolled by one of the authors (P.
K.), and the group assignment was done by another
(S. M.). All received standard anaesthesia with
2.5 ml of bupivacaine (heavy) 0.5% to achieve block
level up to T4. Diclofenac suppository 100 mg was
given at the end of surgery to both of the groups at
8-hourly interval up to 24 h. For the index group,
intravenous (i.v.) acetaminophen was given at the
dose of 1 g every 6 h, starting from the time of
regression of the sensory block to T10. For the
control group, similar procedure was followed using
i.v. tramadol 75 mg at 6-hourly intervals. Both the
test drugs (tramadol and acetaminophen) were
drawn up in similar (Dispovan, Faridabad, Haryana,
India) 10 ml coded syringes and diluted with
normal saline so as to make the final volume of
injection to 10 ml. All patients received i.v. ondanset-
ron 6 mg as a prophylactic anti-emetic according to
hospital protocol.
The primary outcome measure was the summed
pain intensities during the entire observation period,
calculated as the sum of time-weighted pain inten-
sity scores as an area under the curve (AUC). Pain
ratings, at rest and on movement, were measured by
0–10 numeric rating scale (NRS), during the post-
operative period at intervals of 0, 1, 2, 4, 8, 12 and 24 h
(total of seven time points of observation). Effective
pain control was defined as NRS scores ⱕ 3. Pulse,
blood pressure (BP) and respiratory rate were also
noted during this time period. Secondary outcome
measure was the use of supplementary rescue anal-
gesic (meperidine 30 mg i.v., administered if the
patient’s NRS scores ⱖ 4). Side-effect profile and
adverse effects in both groups were noted on a struc-
tured pro forma. Both patients and assessors were
blind to group assignment. Success of blinding,
however, was not assessed.
A structured questionnaire was used for the
groups, documenting their demographic and clini-
cal data, height and weight, co-existing diseases, if
any, known allergies and the details of the operation.
Sample size was calculated with the following
estimates, based on our pilot experience on 15
patients in each group: mean NRS pain score on
movement at 8 h for the tramadol combination
group 1.6 and for the acetaminophen combination
group 2.0, with standard deviation of 1.0 for both of
the groups, setting the power at 80% and alpha as
5%. This yielded a sample of 99 for each group.
Our initial plan was to analyse the primary
outcome data with a general linear model with
repeated-measures analysis of variance (ANOVA)
 Combination analgesia for caesarean section

Table 1
Baseline and clinical characteristics.
Group 1 (diclofenac– Group 2 (diclofenac–
tramadol) n = 103 acetaminophen) n = 101
Mean ⫾ SD Mean ⫾ SD
Age (years) 26.04 ⫾ 3.65 25.92 ⫾ 3.09
Height (cm) 156.15 ⫾ 5.16 156.11 ⫾ 4.91
Weight (kg) 65.17 ⫾ 10.96 63.25 ⫾ 13.98
Duration of surgery (min) 64.57 ⫾ 16.30 62.71 ⫾ 11.73
Blood loss (ml) 602 ⫾ 168.92 632.45 ⫾ 229.15
Baseline pain NRS score at rest 2.40 ⫾ 2.20 2.40 ⫾ 2.13
Baseline pain NRS score at movement 2.77 ⫾ 2.53 2.45 ⫾ 2.07
Baseline heart rate (bpm) 99.65 ⫾ 20.40 91.88 ⫾ 20.32*
Baseline systolic blood pressure (mmHg) 123.72 ⫾ 11.81 119.88 ⫾ 10.49*
Baseline diastolic blood pressure (mmHg) 79.77 ⫾ 11.62 76.51 ⫾ 10.08*
Baseline respiratory rate per minute 18.18 ⫾ 3.81 19.75 ⫾ 3.48

*P < 0.05.
SD, standard deviation; NRS, numeric rating scale.

for computing the main effects for group, time and Assessed for eligibility
(n = 220)
interaction. However, when the NRS pain data were
subjected to Kolmogorov–Smirnov test for normal-
ity, most of the pain score distributions at various Excluded (n = 16)

Enrollment
time points were found to deviate significantly from Not meeting inclusion criteria
(n =11)
Refused to participate
normal distribution. Therefore, parametric statistical Randomized
(n = 5)
Other reasons (n = 0)
analysis was not pursued. The pain data are now
presented as median with interquartile range (IQR).
The longitudinal pain scores for each group were Group 1: Diclofenac + Tramadol Group 2: Diclofenac + Acetaminophen
compared using non-parametric ANOVA (Friedman
test). The overall pain scores were studied by AUC Allocated to intervention (n = 103)
Received allocated intervention (n = 103)
Allocated to intervention (n = 101)
Received allocated intervention (n = 101)
of NRS ¥ time. The groups were compared with
each other at the individual time points by Mann–
Whitney U-test. Alpha was set at 0.05. Because there
was a total seven time points of pain ratings, yield- Lost to follow-up (n = 0) Lost to follow-up (n = 0)
ing seven sets of intergroup comparisons, the Discontinued intervention (n = 0) Discontinued intervention (n = 0)
ensuing higher probability of a type-I error because
of multiple comparisons was corrected by using
Bonferroni correction. Thus, a corrected P value of
0.0071 (0.05 divided by 7) was considered statisti- Analysed (n = 103) Analysed (n = 101)
cally significant. Excluded from analysis (n = 0) Excluded from analysis
(n = 0)

Results Fig. 1. CONSORT flow diagram.

The index group consisted of 101 women aged 18–35
years undergoing caesarean section, to receive sup-
pository diclofenac and injectable acetaminophen.
The control group consisted of 103 women of the
same age range as that of the index group undergo-
ing caesarean section, to receive suppository
diclofenac and injectable tramadol. The data were
collected from March 2008 till September 2009.
Other than baseline (pre-operative) heart rate and
systolic and diastolic blood pressures, which were
significantly higher in the tramadol group, the index
and control groups were comparable on all other
sample characteristics including demographic,
clinical and surgery-related characteristics (Table 1).
The Consolidated Standards of Reporting Trials
(CONSORT) flow diagram is shown in Fig. 1.
The AUC for pain scores across time was signifi-
cantly lower for the diclofenac–tramadol group than
for the diclofenac–acetaminophen group (P = 0.039).
Despite this, the only statistically significant differ-

3
S. Mitra et al.

Table 2 Table 3
Pain scores at rest and on movement. Rescue analgesic requirement.
Group 1 Group 2 P value Group 1 Group 2 P value
(diclofenac– (diclofenac– (Bonferroni (diclofenac– (diclofenac–
tramadol) acetaminophen) corrected) tramadol) acetaminophen)
Median (interquartile range) n = 103 n = 101

NRS at rest Needed, n (%) 13 (12.6) 12 (11.9) 0.872

0h 0 (0–0) 0 (0–0.5) 0.357 Not needed, n (%) 90 (87.4) 89 (88.1)
1h 1 (0–1) 1 (0–1.2) 1.141
2h 1 (0–2) 1.2 (1–2) 0.847
4h 1.4 (1–2.2) 1.5 (1–2) 2.800
8h 1.5 (0.5–2) 1.5 (1.2–2) 0.301 Table 4
12 h 1.4 (1–2) 1.8 (1–2.1) 0.077
24 h 1.4 (0.5–2) 2 (1–2.2) 0.119 Side-effect profile.
NRS on movement Group 1 Group 2 P value
0h 0 (0–0) 0 (0–0.5) 0.714 (diclofenac– (diclofenac–
1h 1 (0–1.5) 1 (0.5–1.9) 0.189 tramadol) acetaminophen)
2h 1.5 (0–2) 1.8 (1–2.2) 0.343 n = 103 n = 101
4h 2 (1–2.5) 2 (1.5–2.5) 0.469
8h 2 (1–2.3) 2 (1.6–2.6) 0.070 Nausea, n (%) 15 (14.6) 2 (2.0) 0.001
12 h 2 (1–2.5) 2 (1.6–2.8) 0.252 Vomiting, n (%) 3 (2.9) 1 (1.0) 0.322
24 h 2 (1–2.5) 2 (1.9–2.6) 0.049* Dizziness, n (%) 7 (6.8) 3 (3.0) 0.206
Headache, n (%) 7 (6.8) 3 (3.0) 0.206
Note: Friedman test for repeated measure of pain scores in Drowsiness, n (%) 2 (1.9) 2 (2.0) 0.986
both groups, both at rest and on movement: P < 0.001. The area Gastritis, n (%) 0 (0.0) 3 (3.0) 0.078
under the curve for the tramadol group as a whole was Sweating, n (%) 1 (1.0) 0 (0.0) 0.321
31.82 whereas that for the acetaminophen group was
38.67 (P = 0.039).
*Significant after Bonferroni correction.
NRS, numeric rating scale.
headache and dizziness (7% each). Other than the
incidence of nausea (P = 0.001), these differences
were statistically non-significant (Table 4).
ence between the two groups emerged at 24 h post-
operative with regard to NRS rating of pain on
Discussion
movement after Bonferroni correction. In all other
instances (13 out of 14 comparisons across seven This study shows that the diclofenac–tramadol
time points), the Bonferroni-corrected P values were group was significantly better than the diclofenac–
statistically non-significant. acetaminophen group as regards overall pain control
Table 2 shows the NRS pain scores at rest and on (as measured by AUC) in women undergoing cae-
movement in the two groups across the seven time sarean section. This is an important result because
points of observation. The overall pain ratings were finding differences between an active treatment
low in both of the groups. Median pain scores and a placebo is much easier and the number of
ranged from 0 to 2 (out of 10) in both of the groups, included patients does not need to be as high as in a
both at rest and on movement. The 75th percentile study that compares two active treatments. This is
scores (upper limit of the IQR) too ranged from 0 to clearly an important highlight of this study.
2.8, thus indicating clinically significant pain control Despite this overall main finding, however,
in both of the groups. The diclofenac–tramadol our study also found that both diclofenac–
group, however, achieved slightly better pain acetaminophen and diclofenac–tramadol combina-
ratings than the diclofenac–acetaminophen group, tions effectively controlled pain in this sample. Pain
especially 8 h onwards. scores, both at rest and on movement, were in the
The secondary outcome measure, rescue analgesic lower range in both of the groups (NRS pain scores
consumption, was comparable between the groups mostly ⱕ 3), and additional rescue opioid analgesic
(13% vs. 12%, P = 0.872, Table 3). Haemodynamic use was comparable between the two groups.
measures were also comparable (data not shown). Regarding the pain score ratings, as mentioned
There were very few side effects in the aceta- earlier, the tramadol group fared better than the
minophen group: nausea (2%), dizziness (3%) and acetaminophen group, with a trend of lower pain
headache (3%). Tramadol group experienced rela- scores in the former especially 8 h post-operative
tively more side effects, especially nausea (15%), onwards, although the intergroup differences

4

reached statistical significance at only 24 h post-
operative with regard to pain on movement out of a
total of seven sets of post-operative observations
and 14 intergroup comparisons.
Side effects of the medications were less in both of
the groups. However, significantly more patients in
the tramadol group reported nausea, despite both
groups having received prophylactic ondansetron.
The diclofenac–acetaminophen combination was
safe during the study period, although observation
over longer term would be needed to confirm this.
While high doses of tramadol can be associated with
serious adverse events, especially seizures, our
patients received a total dose of 300 mg in 24 h,
which is lower than the maximum permissible dose
(400 mg in 24 h).
Several earlier studies and a recent systematic
review have concluded that NSAID–acetaminophen
combination works better than acetaminophen (or
its injectable prodrug, propacetamol) alone, and, to a
lesser extent, than NSAID alone.8 The systematic
review analysed 21 human studies on a total 1909
patients, including eight studies that compared a
combination of diclofenac and acetaminophen (or
propacetamol) with either drug alone. It showed
that NSAID–acetaminophen combination was found
to be more effective in reducing pain and/or sup-
plementary analgesia in 85% of comparisons with
only acetaminophen and 64% of comparisons with
only NSAIDs. Of these, two studies are particularly
notable because these were conducted in patients
undergoing caesarean section and both used
diclofenac as the NSAID, plus either i.v. propaceta-
mol9 or rectal followed by oral acetaminophen.10 The
first study9 found that the combination significantly
reduced supplementary analgesic consumption
compared with propacetamol alone (by 49%) and
diclofenac alone (by 38%). The combination also
reduced pain intensity compared with propacetamol
alone by 37%, but not compared with diclofenac
alone. The second study10 found that the combina-
tion reduced supplementary morphine consump-
tion by 38% compared with acetaminophen alone,
but not with diclofenac alone; pain intensities were
not significantly different among the groups.
Overall, the systematic review concluded that
‘Current evidence suggests that a combination of
paracetamol and an NSAID may offer superior anal-
gesia compared with either drug alone’.8 Another
earlier study had also found that addition of
diclofenac suppository to patient-controlled mor-
phine analgesia in women undergoing caesarean
section had an opioid sparing effect by reducing the
Combination analgesia for caesarean section
consumption of supplementary ketomebidone.11
Thus, there is a reasonable case for using diclofenac–
acetaminophen combination for producing effective
pain control in acute post-operative care including
caesarean section surgery.
The present study differs from the previous ones
by using a different, and more competitive, compa-
rator group in the form of diclofenac–tramadol com-
bination. The comparator group is more competitive
because of two reasons: first, it is a combination
rather than single-drug comparators used in most of
the earlier studies; second, one of the constituents of
the comparator combination is tramadol, an opioid
rather than an NSAID or acetaminophen. In effect,
then, our study has ‘raised the bar’ for demonstrat-
ing the analgesic efficacy of the NSAID–
acetaminophen combination. This may be seen as a
next logical step after the first wave of single-
comparator studies reviewed earlier.3,4,8
It may be argued that the practice of giving
diclofenac and ondansetron to all patients as well as
the effect of prior spinal anaesthesia could have
reduced the ability of the study to detect differences
in pain and nausea between the test drug groups.
The study power and the differences between the
groups might have been larger if only tramadol and
acetaminophen were given as test drugs. The fact
that differences (in pain and nausea) between the
groups were found despite analgesic effect of a
tapering spinal anaesthesia and diclofenac and
ondansetron given to all patients may suggest that
the difference in analgesic efficacy and side effects
(nausea) between tramadol and acetaminophen in
reality might be larger than the differences demon-
strated in the present study. However, studying
only tramadol vs. acetaminophen was not ethically
justifiable because both tramadol and acetami-
nophen are mild analgesics. Further, the currently
used standard combination in our hospital is
diclofenac–tramadol (as multimodal analgesia) and
we wanted to compare this combination with
diclofenac–acetaminophen combination. As shown
in the results, both the combinations were effective
in maintaining overall low pain scores. Hence, we
believe that our main conclusions remain unaltered.
It must be stressed, however, that the AUC com-
parison showed that the diclofenac–tramadol group
was significantly better than the diclofenac–
acetaminophen group as regards overall pain
control.
It would have been interesting to conduct a global
evaluation considering both the analgesic efficacy
and the adverse effects of the study treatments into
5
S. Mitra et al.
consideration in one single outcome measure,
because this integrated outcome measure could
indicate if the superior analgesic effects of
diclofenac–tramadol combination outweighed the
negative emetic effects. This lack of a global evalua-
tion may be considered as a limitation of the study.
The service-related implications of this study
are: first, in regular cases, diclofenac–tramadol com-
bination can be used. Second, however, in any cir-
cumstances where tramadol (or any opioid) use is
considered unsafe or risky, injectable acetami-
nophen can provide an acceptable safe alternative to
tramadol in combination with diclofenac. Thus, the
results of this study expand our therapeutic options
and further empower the clinician in the manage-
ment of this important group of patients.
Overall, it may be concluded that both diclofenac–
acetaminophen and diclofenac–tramadol combina-
tions effectively control pain in women undergoing
caesarean section. The diclofenac–tramadol combi-
nation was overall more efficacious for pain control,
but it was also associated with higher incidence of
post-operative nausea. Our results are in line with
recent publications that suggest the efficacy and
safety of NSAID–acetaminophen combination in
post-operative pain.5,6,7 We now extend this finding
to obstetric cases as well.
Acknowledgement
This work was funded by a grant received from the Department of
Science & Technology (DST), Ministry of Science & Technology,
Government of India (DST Sanction: S&T/RP/11/07/2185–2203
dated 06–12-2007; copy endorsed by GMCH, vide Endst. No.
GMC/TA(20A)2008/1364-70 dated 8/1/2008). DST had no role
in study design, methodology, data collection, analysis and inter-
pretation, report writing or decision to submit the manuscript.
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Address:
Dr Sukanya Mitra
203-B, New Type-V Flats, Sector 24-A
Chandigarh 160023
India
e-mail: drsmitra12@yahoo.com