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

Lloyd R, Derry S, Moore RA, McQuay HJ

Published Online:

November 9, 2011

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.

Abstract (click to read)

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 strategy:

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.

This record should be cited as:

Lloyd R, Derry S, Moore RA, McQuay HJ. Intravenous or intramuscular parecoxib for acute postoperative pain in adults. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.: CD004771. DOI: 10.1002/14651858.CD004771.pub4

Assessed as up to date:

September 15, 2011

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Primary Review Group:

Pain, Palliative and Supportive Care Group

PEARLS - Practical Evidence About Real Life Situations (click to read)

Clinical question:

How effective is parecoxib for acute postoperative pain in adults?

Bottom line:

Single doses of 20mg or 40mg provided effective pain relief in 50 to 60% of treated individuals, compared with 15% treated with placebo. The NNT* at 20mg ranged from 2.1 to 2.8 (median 2.4), and at 40mg from 1.9 to 2.6 (median 2.2). Duration of pain relief was longer with the higher dose (10.6 hours for 40mg versus 6.9 hours for 20mg), 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. *NNT = number needed to treat to benefit 1 individual.

Caveat:

NNTs were lower (better) for the intramuscular than the intravenous route, but the 95% confidence intervals were overlapping, indicating no statistically significant differences between these routes of administration in these studies. It is important to recognise that adverse event analysis after single dose administration will not reflect possible adverse events occurring with use of drugs for longer periods of time. In addition, the relatively small number of participants, even when all the trials were combined, is insufficient to detect rare but serious adverse events (wound infection, cerebrovascular and cardiovascular events, and renal dysfunction).

Context:

Cochrane Systematic Review:

Lloyd R et al. Intravenous or intramuscular parecoxib for acute postoperative pain in adults. Cochrane Reviews 2009, Issue 2. Article No. CD004771.DOI:10.1002/14651858.CD004771.pub4. This review contains 7 studies involving 1446 participants.

Authored by:

Brian R McAvoy

Cochrane Primary Health Care Field

Health topics:

Anaesthesia & pain control > Acute pain > Pharmacological treatment

Anaesthesia & pain control > Peri-anaesthetic/peri-operative care > Post-operative pain

Orthopaedics & trauma > Acute pain > Pharmacological treatment

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

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

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