Journal of Obstetrics and Gynaecology, January 2014; 34: 2528

2014 Informa UK, Ltd.

ISSN 0144-3615 print/ISSN 1364-6893 online
DOI: 10.3109/01443615.2013.828026

OBSTETRICS

Paracetamol vs dexketoprofen for perineal pain relief after episiotomy

or perineal tear
A. Akil1, O. Api2, Y. Bektas3, A. Onan Yilmaz3, S. Yalti1 & O. Unal3
1Bodrum Acbadem Hospital, Bodrum, Mugla, 2Department of Perinatology, Yeditepe University and 3Department of Obstetrics and

Gynecology, Kartal Education and Research Hospital, Istanbul, Turkey

A randomised controlled trial was conducted to investigate

efficacy of paracetamol and dexketoprofen trometamol for
perineal pain relief after perineal repair. Subjects were randomly
assigned to receive two doses of either 50 mg of intravenous
dexketoprofen trometamol via slow i.v. infusion (Group I, n ! 49)
or 1,000 mg of paracetamol via intravenous infusion (Group II,
n ! 46). The main outcome measure was a VAS (visual analogue
scale) for pain recorded at 1 h (VAS 1). A total of 82 patients
were included in the final analysis (Group I, n ! 41; Group II,
n ! 41). There was no difference among groups in terms of pain
scores at the beginning (VAS 0). The pain was decreased in 70%
of the patients in Group I and in 62% of the patients in Group II
(p ! 0.502). Both paracetamol and dexketoprofen are effective in
perineal pain relief after episiotomy or perineal tear repair.
Keywords: Dexketoprofen trometamol, episiotomy, pain,
paracetamol, perineal tear

Introduction
Acute postpartum perineal pain is known to be common
among women undergoing vaginal delivery. However, perineal
pain is reported to be more severe in women with episiotomy
or spontaneous tears when compared with women with intact
perineum (Macarthur and Macarthur 2004). The management
of perineal pain in the early postpartum period is essential,
since it may have a negative impact on the physical and mental functioning of the women. It may consequently lead to
decreased success of the mother for breast-feeding and reduced
ability to care for her new baby; thus it may impair the establishment of a good quality motherbaby interaction (Grant and
Sleep 1989).
Numerous treatment modalities, including topical anaesthetics, oral, simple and narcotic analgesics and non-pharmacological applications in the form of gels, creams or ice packs, are
used to alleviate perineal pain in clinical practice (Sleep and
Grant 1988). When perineal pain is mild, paracetamol is the
most commonly used analgesic in clinical practice (Hedayati
et al. 2003). Maternal ingestion of paracetamol in usual analgesic doses does not appear to present a risk to breast-fed infants,
since it is excreted in small amounts (! 0.2%) in the breast milk
(Bitzn et al. 1981).
On the other hand, non-steroidal anti-inflammatory drugs
(NSAIDs) are also used commonly in the perineal pain control.
As an example, diclofenac and ibuprofen are two of the NSAIDs

tested and shown to be effective for the treatment of postepisiotomy pain (Peter et al. 2001; Dodd et al. 2004; Yildizhan
et al. 2009).
Since some women, especially with significant perineal
trauma, experience more severe and prolonged discomfort, they
may need different or more effective treatment modalities such as
single-dose epidural narcotics used for post-caesarean analgesia
(Hedayati et al. 2003).
Dexketoprofen trometamol is a relatively new NSAID, which
is the active enantiomer of racemic ketoprofen. When compared with ketoprofen, dexketoprofen possesses the advantages
of faster onset of action, increased potency, fewer gastrointestinal side-effects (Mercorio et al. 2002; Iohom et al. 2002).
Dexketoprofen has been commonly used for management of
acute and chronic pain in different clinical situations such as
orthopaedic, general and major gynaecological surgical procedures and found to be non-inferior to other NSAIDs and paracetamol/opioid combinations (Mercorio et al. 2002; Iohom et al.
2002; Ezcurdia et al. 1998). In a trial investigating the use of
dexketoprofen in minor gynaecological surgery, it was found to
produce a satisfactory level of analgesia, similar to that achieved
with paracervical block during diagnostic hysteroscopy in
postmenopausal women (Mercorio et al. 2002). Furthermore,
ketoprofen has also been found to effectively reduce the need
for pain treatment after caesarean section and the requirement
for opioids to be decreased by about 40% (Rorarius et al. 1993).
However, there is no available study evaluating the effectiveness
of ketoprofen or dexketoprofen in episiotomy pain. Since ketoprofen is known to be excreted in only traces or small amounts
in breast milk (Jacqz-Aigrain et al. 2007), it was thought to be
a safe alternative to paracetamol in the management of early
postpartum perineal pain.
In this randomised controlled study, we aimed to compare the
analgesic efficacy of intravenous paracetamol with intravenous
dexketoprofen trometamol in reducing perineal pain after vaginal
delivery.

Materials and methods

A randomised, double-blind trial was conducted to compare
the analgesic efficacy of i.v. paracetamol 1,000 mg with i.v.
dexketoprofen trometamol 50 mg, for pain relief after perineal
repair following vaginal delivery. The study was conducted at
Dr Lutfi Kirdar Kartal Teaching and Research Hospital, Department of Obstetrics and Gynecology between April and June

Correspondence: A. Akil, Bodrum Acbadem Hospital, Bodrum, Mugla, Turkey. E-mail: zkubat@yahoo.com

26

A. Akil et al.

2009. Ethical approval for the study was granted by the local
ethical committee.
The study population consisted of women who had episiotomy
or perineal tear that required repair after vaginal delivery. Neither
epidural nor combined spinalepidural analgesia was used in any
of the patients. Exclusion criteria included: women who had a
known allergy to NSAIDs or paracetamol; any known disease
contraindicating the use of NSAIDs (severe asthma, gastric or
duodenal ulcer) or paracetamol; complicating maternal diseases
(pregestational/gestational diabetes mellitus; bleeding disorders;
pre-eclampsia and other hypertensive disorders of pregnancy);
ablatio placenta; severe postpartum haemorrhage (" 1,500 ml);
inability to understand how to score a 10 cm visual analogue
scale (VAS).
Prior to the study, sample size calculation was performed to
avoid type II error. The standard deviation of pain scores following perineal repair after vaginal birth was obtained from previously published studies. Sample size calculations were based on
previous research carried out by Lim et al. (2008), which showed
a mean pain score of 2.2 (SD 1.8), using a 10-point VAS scale for
perineal pain at 1 hour post-perineal repair. We calculated that to
detect an at least 1-point difference on a 10-point VAS for pain
using the t-test, assuming standard deviation of 1.5, alpha of 0.05
and power of 80%, would require 36 women in each drug arm.
Assuming a 20% dropout rate, a minimum of 86 women was
calculated to be recruited. Block randomisation was achieved by
using a computer-generated random number chart (SPSS Inc.,
Version 11.0 for Windows, Chicago IL) before the study. Consecutive numbers generated by the computer were written on
the numbered opaque envelopes, which were sealed by someone
other than those involved in the study, with the data inside indicating treatment allocation as P (paracetamol) or D (dexketoprofen). Following vaginal delivery, within 5 min after completion of
suturing, the written informed consents were obtained from all
of the patients and the patients were randomised into one of the
two study groups. All women were informed that rescue analgesia
with the same or different drugs would be available if pain relief
was inadequate and breast-feeding was not contraindicated with
any of the study drugs.
The women involved in the study were blinded to the allocated treatment group. All patients were routinely inserted an i.v.
cannulae during labour and the study drugs were administered
through this cannulae via slow infusion. Patients in Group I were
administered two doses of 50 mg i.v. dexketoprofen trometamol
(Arveles; IE Ulagay Pharmaceutical, Istanbul, Turkey) and
patients in Group II were administered two doses of 1,000 mg
i.v. paracetamol (Perfalgan; 10 mg/ml; Bristol-Myers Squibb
GmbH); the first dose given at the 5th minute after completion of
suturing and the second dose 6 hours later. Patients in both of the
groups had also placebo injections mimicking the active drug.
All patients were administered local anaesthesia by 2% lidocaine (Jetokain Simplex ampule; Adeka Pharmaceutical Company, Istanbul, Turkey) while episiotomy or tear was cut, and also
extra doses of lidocaine were administered if necessary, while
it was being repaired. Mediolateral episiotomy and 1st or 2nd
degree perineal tears were repaired in layers with a No. 0 absorbable, coated suture made of polyglycolic acid (Vicryl, Ethicon,
Inc). The perineal skin was closed with No. 2/0 interrupted sutures
of polyglycolic acid (Vicryl, Ethicon, Inc). The repair time was
similar between the groups. The episiotomy and perineal tear
repairing was performed by the two same gynaecologists (YB,
AOY) to minimise the risk of technical variation. The women
received standard postnatal care in the maternity ward and were
mobilised as soon as could be tolerated.

All patients were asked to rate their pain level on a 10 cm

VAS from zero (no pain) to 10 (worst pain ever). Pain scoring
was performed at six different time points: at the 5th min after
completion of suturing (VASt0); and 1 (VAS t1); 2 (VASt2); 3
(VASt3); 6 (VASt6); and 12 hours later (VASt12) than the first dose
of the drug. No further follow-up was scheduled. The patients
were reminded by the maternity ward nurses to complete their
VAS scales at the given time points. They were also encouraged
to inform the nurses about any adverse symptoms that may be
related to the drug use, such as nausea, headache, epigastric pain,
etc. Patient demographics such as age, parity, maternal weight
and height and obstetric history were documented. The primary
outcome measures were VASt1 and the secondary outcome measures were VASt6, VASt12.
Data were analysed using the SPSS 13.0 (SPSS Inc). Statistical analysis was performed with MannWhitney U test, Students t-test and paired t-test, where appropriate. A p value of
! 0.05 (95% confidence interval, CI) was considered as statistically significant. The analysis was performed on an intentionto-treat basis.

Results
A total of 95 patients were randomised to receive the study drug:
49 patients to dexketoprofen and 46 patients to paracetamol. Ten
patients were excluded because of extra analgesic need (six in the
dexketoprofen group and four in the paracetamol group). In total,
82 patients had complete data to be available to the final analysis.
The flowchart of the patients is shown in Figure 1.
The demographics and baseline characteristics of the women
in both groups are shown in Table I. Except gravidity, there were
no significant differences in sociodemographic data or baseline
parameters (parity, age, the length of the labour, birth weight,
dose of the local anaesthetic used during the repair of episiotomy
or perineal tears (lidocaine) and VAS 0 among the two groups
(p # 0.02 for gravidity). There were no statistically differences in
the number of patients who underwent episiotomy and repair of
lacerations between the two groups. There were no cases of 3rd or
higher degree perineal tears or instrumental vaginal delivery.
The mean pain scores in the two groups revealed significant
reductions from the beginning at the first hour (Group I, p ! 0.0001;
Group II, p # 0.04). Mean VAS pain score declined in 31/41 patients
in group I (%75.6) and 25/41 patients in group II (%60.9) (p # 0.15

Figure 1. Recruitment flowchart for randomised trial of paracetamol and

dexketoprofen after perineal pain following episiotomy or perineal tear
repair.

Pain relief after episiotomy or perineal tear 27

Table I. Demographics and characteristics of the women randomised to
paracetamol or dexketoprofen for perineal pain after episiotomy or perineal
tear repair (mean $ SD).

Age (years)
Height (cm)
Weight (kg)
Gravidity
Parity
Length of labour (h)
Birth weight (g)
Lidocaine dose (mg)
VAS 0 score

Group I:
Dexketoprofen

Group II:
Paracetamol

24.71 $ 5.83
161.23 $ 5.56
66.08 $ 8.3
1.85 $ 1.29
1.20 $ 1.01
9.43 $ 14.9
3163.9 $ 588.9
108.4 $ 40.4
31.1 $ 23.5

24.71 $ 4.91
161.97 $ 5.65
72.21 $ 10.65
1.55 $ 0.75
0.74 $ 0.69
6.05 $ 5.28
3257.38 $ 500.5
110.4 $ 47.2
26.5 $ 25.1

between groups). There were no statistically significant difference

in the amount of reduction in VAS scores in terms of VAS 2, 3, 6
and 12 between the groups (p " 0.05) (Table II, Figure 2).
In the comparison between treatment groups, there was no
statistically significant difference in VAS 1, VAS 2, VAS 6, and
VAS 12 scores. In Group I, VASt2 was statistically significantly
lower than VASt1 (p # 0.007). In the group of patients allocated to
receive dexketoprofen (Group I), there was no statistically significant difference in the other pain scores, but in the patients who
received paracetamol, there was a significant decline between
the values of VAS 1 VAS 2 and VAS 3 VAS 6 (p # 0.026 and
p # 0.004, respectively).
No treatment-related adverse effect was reported in any of the
patients. The total costs of the two study drugs were not statistically different.

Discussion
The aim of this randomised controlled study was to assess the
analgesic efficacy of a non-steroid anti-inflammatory drug,
dexketoprofen, compared with paracetamol for perineal pain after
perineal repair. The self-assessments of pain with a 10 cm VAS
showed that, administration of both intravenous paracetamol and
dexketoprofen were similarly effective in perineal pain relief.
Although it is no longer recommended to have routine episiotomy (Shahraki et al. 2011), in Turkey, still the majority of
women who give birth by the vaginal route have episiotomy to
prevent undesirable tearing or significant labial or vaginal lacerations. Episiotomy or spontaneous tearing of perineal tissues
during vaginal birth is associated with significant pain, infection
and loss of mobility during the immediate postpartum period
(Hedayati et al. 2005). Perineal pain can also have negative
impacts on a womans daily activities, including sleep patterns,
urinary and bowel function and providing practical care of her
infant (Hedayati et al. 2003). Perineal pain is reported to be most
Table II. Mean reductions in the VAS scores between the two groups.
Group I: Dexketoprofen
(n # 41)

VASt0VASt1
VASt1VASt2
VASt2VASt3
VASt3VASt6
VASt6VASt12

Group II: Paracetamol

(n # 41)

Reduction
(mean $ SD)

p value

Reduction
(mean $ SD)

p value

12.14 $ 19.3
5.65 $ 12.8
0.32 $ 8.8
2.05 $ 8.05
0.97 $ 11.1

! 0.0001
0.007
0.82
0.11
0.57

7.7 $ 16.3
2.7 $ 10.1
1.04 $ 11.4
2.72 $ 9.4
1.1 $ 12.2

0.004
0.09
0.56
0.07
0.57

Figure 2. VAS scores in the two groups in dierent time points. Dierences
between the groups were not statistically significant.

severe in the immediate postnatal period; however, discomfort

continues for up to 2 weeks postpartum in 2025% of women
(Hedayati et al. 2003).
As pain increases to moderate and severe levels, a variety of
drugs have been used but very few of these are free of side-effects.
Studies addressing options for perineal pain management have
included the use of analgesics given orally or per rectum as well as
topical applications (Hedayati et al. 2003, 2005). Non-pharmacological methods of pain management (e.g. application of heat or
cold, or sitting baths) are often inadequate.
An important issue associated with postpartum analgesic
use is the potential passage into breast milk. When prescribing
pain medication to women in their postpartum period who are
breast-feeding, it is important to consider the safety of the drug
to the newborn infant in addition to the clinical effectiveness to
the mother. Some analgesics, such as acetaminophen, ibuprofen and codeine, are usually compatible with breast-feeding but
drugs such as aspirin have been linked to significant effects on the
infant, such as metabolic acidosis and hence are contraindicated
(AAPCD 2001).
In clinical practice, the most frequently used and the best
safe known analgesic is paracetamol in breast-feeding mothers.
According to a pharmacodynamics study conducted by Bitzn
et al. (1981), ! 0.1% of the maternal dose would be present in
100 ml milk. The authors concluded that breast-feeding need not
be discontinued due to paracetamol treatment in conventional
dosage placebo against the episiotomy pain (Skovlund et al.
1991). For these reasons, we decided to use paracetamol as the
reference drug.
NSAIDs such as diclofenac and indomethacin have been
shown in recent studies to be effective in the management of
postoperative pain following obstetric (Bush et al. 1992) and
gynaecological (Carlborg et al. 1987) procedures. Non-steroidal
anti-inflammatory drugs exert their analgesic action via several
pathways, including prostaglandin modulation supraspinally and
spinally (McQuay et al. 1989; Gertzbein et al. 1986). Because of
a different mechanism of action, NSAIDs are devoid of opioidrelated adverse effects. It appears that short-term treatment is
relatively free of adverse effects unless there is a pre-existing contraindication to use these drugs, such as gastric ulcer or coagulopathy (Vane 1971; Kellstein et al. 1999). Both the Food and Drug
Administration and the American Academy of Pediatrics label
NSAIDs as compatible with breast-feeding (Nauta et al. 2009).
Ketoprofen is frequently used to prevent and treat postpartum pain. Ketoprofen administered to the mother just after birth
has been demonstrated to be effective in reducing postpartum
pain secondary to episiotomy or caesarean section, and it is now

28

A. Akil et al.

used increasingly during the postpartum period (Jacqz-Aigrain

et al. 2007). In a study by Roraius et al. (1993), ketoprofen was
demonstrated to be significantly more effective than placebo and
to be equivalent to diclofenac in reducing pain and increasing
patient comfort. In addition, a single dose of ketoprofen (50 or
100 mg) was more effective than aspirin (650 mg) or placebo in
reducing postpartum pain (Sunshine et al. 1986). Furthermore,
in a study conducted to quantify the transfer of ketoprofen in
milk, ketoprofen concentrations were determined with highperformance liquid chromatography and the amount transferred
into breast milk and ingested by the nursing baby was found to
be small, so breast-feeding was concluded to be permissible when
ketoprofen was administered to the mother to treat postpartum
pain (Jacqz-Aigrain et al. 2007).
Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of ketoprofen. The more rapid onset of
action compared with ketoprofen suggests that dexketoprofen
trometamol is more appropriate for treatment of acute pain
(McGurk et al. 1998).
To the best of our knowledge, there is no clinical study to
compare dexketoprofen trometamol as a pain reliever after postpartum episiotomy of perineal tear repair, until now. The purpose
of this study was to compare, in a randomised double-blinded
design, dexketoprofen trometamol with paracetamol soon after
vaginal birth, to reduce perineal pain. Postpartum pain relief was
assessed by measurement on a visual analogue scale.
In our study, comparing paracetamol and dexketoprofen trometamol in relieving perineal pain in a randomised controlled
manner, both drugs were found equally effective in our patients.
In the comparison between treatment groups, there was no statistically significant difference in the reductions in VASt2, VASt6,
and VASt12 scores. In both of the groups, there was a significant
decline between the values of VASt0VASt1 and also in the dexketoprofen group, there was a significant decline between the values
of VASt1VASt2, which may resemble a slightly longer effect with
dexketoprofen infusion. Knowing that the discomfort which
these women feel continues for up to days after vaginal birth, a
long-term efficacy may be a desired effect.
As a conclusion, even if paracetamol and dexketoprofen trometamol are both effective methods for reducing the pain after
the repair of episiotomy or perineal tears, we may suggest the
routine use of dexketoprofen infusion because of its apparently
longer-lasting effect as the drug of choice in the women experiencing perineal pain due to episiotomy or perineal repair after
vaginal birth.
Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing
of the paper.

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