Intravenous or intramuscular parecoxib for acute postoperative pain in adults

Abstract

Background

Parecoxib was the first COX‐2 available for parenteral administration, and may, given intravenously or intramuscularly, offer advantages over oral medication when patients have nausea and vomiting or are unable to swallow, such as in the immediate postoperative period.

Objectives

Assess the efficacy of single dose intravenous or intramuscular parecoxib in acute postoperative pain, the requirement for rescue medication, and any associated adverse events.

Search methods

We searched Cochrane CENTRAL, MEDLINE, EMBASE in November 2008.

Selection criteria

Randomised, double‐blind, placebo‐controlled clinical trials of parecoxib compared with placebo for relief of acute postoperative pain in adults.

Data collection and analysis

Two review authors independently assessed trial quality and extracted data. The area under the “pain relief versus time” curve was used to derive the proportion of participants with parecoxib and placebo experiencing at least 50% pain relief over 6 hours, using validated equations. The number‐needed‐to‐treat‐to‐benefit (NNT) was calculated using 95% confidence intervals (CI). The proportion of participants using rescue analgesia over a specified time period, and time to use of rescue analgesia, were sought as additional measures of efficacy. Information on adverse events and withdrawals were also collected.

Main results

Seven studies (1446 participants) were included. There was no significant difference between doses, or between intravenous and intramuscular administration for 50% pain relief over 6 hours: NNTs compared with placebo were 3.1 (2.4 to 4.5), 2.4 (2.1 to 2.8), and 1.8 (1.5 to 2.3) for 10, 20, and 40 mg parecoxib respectively. Fewer participants required rescue medication over 24 hours with parecoxib than placebo: parecoxib 40 mg was significantly better than parecoxib 20 mg (NNTs to prevent use of rescue medication 7.5 (5.3 to 12.8) and 3.3 (2.6 to 4.5) respectively; P < 0.0007). Median time to use of rescue medication was 3.1 hours, 6.9 hours and 10.6 hours with parecoxib 10 mg, 20 mg and 40 mg respectively, and 1.5 hours with placebo. Adverse events were generally mild to moderate, rarely led to withdrawal, and did not differ in frequency between groups. No serious adverse events were reported with parecoxib or placebo.

Authors' conclusions

A single dose of parecoxib 20 mg or 40 mg provided effective analgesia for 50 to 60% of those treated compared to about 15% with placebo, and was well tolerated. Duration of analgesia was longer, and significantly fewer participants required rescue medication over 24 hours with the higher dose.

Author(s)

Rosalind Lloyd, Sheena Derry, R Andrew Moore, Henry J McQuay

Abstract

Plain language summary

Parecoxib delivered intramuscularly or intravenously (injected in to the muscle or the vein) for acute postoperative pain in adults

The most common route for administration of postoperative analgesia is by mouth, but some patients are unable to swallow, feel nauseated, or vomit in the immediate postoperative period, and in these patients intravenous or intramuscular administration may be preferred. This review assessed seven studies of parecoxib, an injectable COX‐2 inhibitor, for acute postoperative pain relief. Single doses of 20 mg or 40 mg provided effective pain relief in 50 to 60% of treated individuals, compared with 15% treated with placebo. Duration of pain relief was longer with the higher dose (10.6 hours for 40 mg versus 6.9 hours for 20 mg), and significantly fewer individuals on the higher dose required rescue medication over 24 hours (66% versus 81%). Adverse events were generally mild to moderate in severity and were reported by just over half of treated individuals in both parecoxib and placebo groups.

Author(s)

Rosalind Lloyd, Sheena Derry, R Andrew Moore, Henry J McQuay

Reviewer's Conclusions

Authors' conclusions 

Implications for practice 

Parecoxib is an effective analgesic in postoperative pain with a low incidence of adverse events when given as a single dose. At a dose of 20 mg to 40 mg it provided effective analgesia for 50 to 60% of patients with moderate to severe postoperative pain following various types of surgery. For every two participants treated with parecoxib 20 mg or 40 mg, one would experience at least 50% pain relief who would not have done so with placebo. Associated adverse events were generally mild to moderate in intensity.

Implications for research 

Additional data is required to confirm the results of this review and provide a more robust estimate of efficacy, particularly for the lower doses. Further data for the lower doses will help determine the minimum effective dose and establish a dose response for parecoxib. In clinical practice the aim should always be to use the lowest dose possible to achieve the desired benefit with minimal risk of adverse events. More data for the intravenous and intramuscular routes will help to decide which route of administration is most effective for parecoxib in the clinical setting, while more data from different types of surgery may help determine whether there are clinically important differences between them.

Get full text at The Cochrane Library