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Meta-Analysis
. 2016 Jul 14;7(7):CD011352.
doi: 10.1002/14651858.CD011352.pub2.

Oral non-steroidal anti-inflammatory drugs (single dose) for perineal pain in the early postpartum period

Francesca Wuytack  1 , Valerie Smith, Brian J Cleary
Affiliations
Meta-Analysis

Oral non-steroidal anti-inflammatory drugs (single dose) for perineal pain in the early postpartum period

Francesca Wuytack et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Many women experience perineal pain after childbirth, especially after having sustained perineal trauma. Perineal pain-management strategies are thus an important part of postnatal care. Non-steroidal anti-inflammatory drugs (NSAIDs) are a commonly used type of medication in the management of postpartum pain and their effectiveness and safety should be assessed.

Objectives: To determine the effectiveness of a single dose of an oral NSAID for relief of acute perineal pain in the early postpartum period.

Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2016), OpenSIGLE, ProQuest Dissertations and Theses, the ISRCTN Registry and ClinicalTrials.gov (31 March 2016). We also reviewed reference lists of retrieved papers and contacted experts in the field.

Selection criteria: Randomised controlled trials (RCTs) assessing a single dose of a NSAID versus a single dose of placebo, paracetamol or another NSAID for women with perineal pain in the early postpartum period. Quasi-RCTs and cross-over trials were excluded.

Data collection and analysis: Two review authors (FW and VS) independently assessed all identified papers for inclusion and risk of bias. Any discrepancies were resolved through discussion and consensus. Data extraction, including calculations of pain relief scores, was also conducted independently by two review authors and checked for accuracy.

Main results: We included 28 studies that examined 13 different NSAIDs and involved 4181 women (none of whom were breastfeeding). Studies were published between 1967 and 2013, with the majority published in the 1980s. Of the 4181 women involved in the studies, 2642 received a NSAID and 1539 received placebo or paracetamol. Risk of bias was generally unclear due to poor reporting, but in most studies the participants and personnel were blinded, outcome data were complete and the outcomes that were specified in the methods section were reported.None of the included studies reported on any of this review's secondary outcomes: prolonged hospitalisation or re-hospitalisation due to perineal pain; breastfeeding (fully or mixed) at discharge; breastfeeding (fully or mixed) at six weeks; perineal pain at six weeks; maternal views; postpartum depression; instrumental measures of disability due to perineal pain. NSAID versus placeboCompared to women who received a placebo, more women who received a single dose NSAID achieved adequate pain relief at four hours (risk ratio (RR) 1.91, 95% confidence interval (CI) 1.64 to 2.23, 10 studies, 1573 participants (low-quality evidence)) and adequate pain relief at six hours (RR 1.92, 95% CI 1.69 to 2.17, 17 studies, 2079 participants (very low-quality evidence)). Women who received a NSAID were also less likely to need additional analgesia compared to women who received placebo at four hours (RR 0.39, 95% CI 0.26 to 0.58, four studies, 486 participants (low-quality evidence)) and at six hours after initial administration (RR 0.32, 95% CI 0.26 to 0.40, 10 studies, 1012 participants (low-quality evidence)). Fourteen maternal adverse effects were reported in the NSAID group (drowsiness (5), abdominal discomfort (2), weakness (1), dizziness (2), headache (2), moderate epigastralgia (1), not specified (1)) and eight in the placebo group (drowsiness (2), light headed (1), nausea (1), backache (1), dizziness (1), epigastric pain (1), not specified (1)), although not all studies assessed adverse effects. There was no difference in overall maternal adverse effects between NSAIDs and placebo at six hours post-administration (RR 1.38, 95% CI 0.71 to 2.70, 13 studies, 1388 participants (very low-quality evidence)). One small study (with two treatment arms) assessed maternal adverse effects at four hours post-administration, but there were no maternal adverse effects observed (one study, 90 participants (low-quality evidence)). Neonatal adverse effects were not assessed in any of the included studies. NSAID versus paracetamolNSAIDs versus paracetamol were also more effective for adequate pain relief at four hours (RR 1.54, 95% CI 1.07 to 2.22, three studies, 342 participants) but not at six hours post-administration. There was no difference in the need for additional analgesia between the two groups at four hours (RR 0.55, 95% CI 0.27 to 1.13, one study, 73 participants), but women in the NSAID group were less likely to need any additional analgesia at six hours (RR 0.28, 95% CI 0.12 to 0.67, one study, 59 participants). No maternal adverse effects were reported four hours after drug administration (one study). Six hours post-administration, there was no difference between the groups in the number of maternal adverse effects (RR 0.74, 95% CI 0.27 to 2.08, three studies, 300 participants), with one case of pruritis in the NSAID group and one case of sleepiness in the paracetamol group. Neonatal adverse effects were not assessed in any of the included studies.Comparisons of different NSAIDs and different doses of the same NSAID did not demonstrate any differences in their effectiveness on any of the primary outcome measures; however, few data were available on some NSAIDs.

Authors' conclusions: In women who are not breastfeeding and who sustained perineal trauma, NSAIDs (compared to placebo) provide greater pain relief for acute postpartum perineal pain and fewer women need additional analgesia when treated with a NSAID. However, the risk of bias was unclear for many of the included studies, adverse effects were often not assessed and breastfeeding women were not included in the studies. The overall quality of the evidence (GRADE) was low with the evidence for all outcomes rated as low or very low. The main reasons for downgrading were inclusion of studies with high risk of bias and inconsistency of findings of individual studies.NSAIDs also appear to be more effective in providing relief for perineal pain than paracetamol, but few studies were included in this analysis.Future studies should examine NSAIDs' adverse effects profile including neonatal adverse effects and the compatibility of NSAIDs with breastfeeding, and assess other important secondary outcomes of this review. Moreover, studies mostly included women who had episiotomies. Future research should consider women with and without perineal trauma, including perineal tears. High-quality studies should be conducted to further assess the efficacy of NSAIDs versus paracetamol and the efficacy of multimodal treatments.

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Conflict of interest statement

Francesca Wuytack: has received a Cochrane Fellowship, awarded by the Health Research Board Ireland, to support the conduct of this review.

Valerie Smith has acted in the capacity of Ms Wuytack's supervisor and PI on the Cochrane HRB Fellowship grant application. The awarded grant is not salary or such support, rather support for Ms Wuytack to attend Cochrane training workshops and other necessary consumables.

Brian J Cleary's institution has received €500from the State Claims Agency for a lecture that he gave about the historical context of the development and marketing of thalidomide in Ireland to a mediation process between the Irish state and survivors of the Thalidomide disaster. A sum of €1500 was also paid to his institution (by Ferring Pharmaceuticals) for training provided to private sector pharmacies and an infertility clinic on the use of a specialised drug delivery system used to delivery an infertility treatment from Ferring (Lutrelef). Brian's brother works for a drug company that sells analgesic products (Grunenthal). However Brian's institution does not currently use their products for the management of peripartum pain and their products are irrelevant to the content of this review. Brian has been publicly critical of Grunenthal and their historical actions in the context of the thalidomide disaster.

Figures

Figure 1
Figure 1
Study flow diagram.
Figure 2
Figure 2
'Risk of bias' graph: review authors' judgements on each risk of bias item presented as percentages across all included studies.
Figure 3
Figure 3
'Risk of bias' summary: review authors' judgements on each risk of bias item for each included study.
Figure 4
Figure 4
Funnel plot of comparison: 1 NSAID (single administration, any dose) versus placebo, outcome: 1.1 Adequate pain relief (4 hours after administration).
Figure 5
Figure 5
Funnel plot of comparison: 1 NSAID (single administration, any dose) versus placebo, outcome: 1.2 Adequate pain relief (6 hours after administration).
Figure 6
Figure 6
Funnel plot of comparison: 1 NSAID (single administration, any dose) versus placebo, outcome: 1.4 Need for additional analgesia (6 hours after administration).
Figure 7
Figure 7
Funnel plot of comparison: 1 NSAID (single administration, any dose) versus placebo, outcome: 1.6 Maternal drug adverse effects (6 hours after administration).
Analysis 1.1
Analysis 1.1
Comparison 1 NSAID (single administration, any dose) versus placebo, Outcome 1 Adequate pain relief (4 hours after administration).
Analysis 1.2
Analysis 1.2
Comparison 1 NSAID (single administration, any dose) versus placebo, Outcome 2 Adequate pain relief (6 hours after administration).
Analysis 1.3
Analysis 1.3
Comparison 1 NSAID (single administration, any dose) versus placebo, Outcome 3 Need for additional analgesia (4 hours after administration).
Analysis 1.4
Analysis 1.4
Comparison 1 NSAID (single administration, any dose) versus placebo, Outcome 4 Need for additional analgesia (6 hours after administration).
Analysis 1.5
Analysis 1.5
Comparison 1 NSAID (single administration, any dose) versus placebo, Outcome 5 Maternal drug adverse effects (4 hours after administration).
Analysis 1.6
Analysis 1.6
Comparison 1 NSAID (single administration, any dose) versus placebo, Outcome 6 Maternal drug adverse effects (6 hours after administration).
Analysis 2.1
Analysis 2.1
Comparison 2 NSAID (single administration, any dose) versus paracetamol, Outcome 1 Adequate pain relief (4 hours after administration).
Analysis 2.2
Analysis 2.2
Comparison 2 NSAID (single administration, any dose) versus paracetamol, Outcome 2 Adequate pain relief (6 hours after administration).
Analysis 2.3
Analysis 2.3
Comparison 2 NSAID (single administration, any dose) versus paracetamol, Outcome 3 Need for additional analgesia (4 hours after administration).
Analysis 2.4
Analysis 2.4
Comparison 2 NSAID (single administration, any dose) versus paracetamol, Outcome 4 Need for additional analgesia (6 hours after administration).
Analysis 2.5
Analysis 2.5
Comparison 2 NSAID (single administration, any dose) versus paracetamol, Outcome 5 Maternal drug adverse effects (4 hours after administration).
Analysis 2.6
Analysis 2.6
Comparison 2 NSAID (single administration, any dose) versus paracetamol, Outcome 6 Maternal drug adverse effects (6 hours after administration).
Analysis 3.1
Analysis 3.1
Comparison 3 NSAID versus a different NSAID, Outcome 1 Adequate pain relief (4 hours after administration).
Analysis 3.2
Analysis 3.2
Comparison 3 NSAID versus a different NSAID, Outcome 2 Adequate pain relief (6 hours after administration).
Analysis 3.3
Analysis 3.3
Comparison 3 NSAID versus a different NSAID, Outcome 3 Need for additional analgesia (4 hours after administration).
Analysis 3.4
Analysis 3.4
Comparison 3 NSAID versus a different NSAID, Outcome 4 Need for additional analgesia (6 hours after administration).
Analysis 3.5
Analysis 3.5
Comparison 3 NSAID versus a different NSAID, Outcome 5 Maternal drug adverse effects (4 hours after administration).
Analysis 3.6
Analysis 3.6
Comparison 3 NSAID versus a different NSAID, Outcome 6 Maternal drug adverse effects (6 hours after administration).
Analysis 4.1
Analysis 4.1
Comparison 4 NSAID versus a different dose of the same NSAID, Outcome 1 Adequate pain relief (4 hours after administration).
Analysis 4.2
Analysis 4.2
Comparison 4 NSAID versus a different dose of the same NSAID, Outcome 2 Adequate pain relief (6 hours after administration).
Analysis 4.3
Analysis 4.3
Comparison 4 NSAID versus a different dose of the same NSAID, Outcome 3 Need for additional analgesia (4 hours after administration).
Analysis 4.4
Analysis 4.4
Comparison 4 NSAID versus a different dose of the same NSAID, Outcome 4 Need for additional analgesia (6 hours after administration).
Analysis 4.5
Analysis 4.5
Comparison 4 NSAID versus a different dose of the same NSAID, Outcome 5 Maternal drug adverse effects (4 hours after administration).
Analysis 4.6
Analysis 4.6
Comparison 4 NSAID versus a different dose of the same NSAID, Outcome 6 Maternal drug adverse effects (6 hours after administration).
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References

References to studies included in this review

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References to other published versions of this review

    1. Wuytack F, Smith V. Oral non‐steroidal anti‐inflammatory drugs (single dose) for perineal pain in the early postpartum period. Cochrane Database of Systematic Reviews 2014, Issue 10. [DOI: 10.1002/14651858.CD011352] - DOI - PubMed

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