Key messages
• Ibuprofen probably reduces pain intensity just after an operation up to two hours compared to a placebo (dummy) and compared to paracetamol. The evidence compared to other medicines and in the longer term is unclear or lacking.
• Overall, we are uncertain about unwanted effects of ibuprofen, especially serious unwanted effects, since the studies in the review rarely measured them.
• Future studies should examine ibuprofen compared to commonly used medications and measure benefits and unwanted effects for both short- and long-term use.
Why is pain management important?
It is common for children to experience pain after an operation (postoperative pain). Pain causes suffering and agitation, and it can delay recovery. One way to manage pain in children is by using different medicines, for example, ibuprofen. Ibuprofen is a type of medicine called a 'non-steroidal anti-inflammatory drug' (NSAID) that can reduce inflammation and pain.
What did we want to find out?
We wanted to find out if ibuprofen is an effective pain treatment and whether it causes unwanted effects compared to other pain treatments. Also, the most effective way to deliver ibuprofen to children.
What did we do?
We searched for studies that compared ibuprofen to other treatment options for postoperative pain as well as for studies that looked at different ways to deliver ibuprofen to children. We summarised the results and rated our confidence in the evidence.
What did we find?
We found 43 studies with 4265 children with postoperative pain. We used data from 3935 children in this review. The largest study included 741 children and the smallest, 23 children. The studies were conducted in many countries around the world; most commonly the USA (12 studies). Children's ages ranged from 2.2 months up to 17 years. Studies used ibuprofen to manage postoperative pain in 10 different types of surgery: mostly dental procedures (21 studies); and ear, nose and throat procedures (11 studies).
Main results
Compared to placebo (a dummy medicine), ibuprofen probably reduces pain intensity less than two hours after the operation and may reduce pain intensity up to 24 hours. We are unsure about differences for any unwanted effects. No studies reported serious unwanted effects, such as lasting disability or hospitalisation.
Compared to paracetamol, ibuprofen probably reduces pain intensity less than two hours after the operation and probably reduces pain intensity up to 24 hours. We are unsure about differences for any unwanted effects. No studies reported serious unwanted effects, such as lasting disability or hospitalisation. Compared to paracetamol, ibuprofen probably makes little difference to the chances of bleeding.
Compared to morphine, ibuprofen probably leads to a reduction in any reported unwanted effects.
Compared to ketorolac, ibuprofen may lead to a reduction in overall harms.
No studies reported pain intensity or serious unwanted effects, such as lasting disability or hospitalisation for either morphine or ketorolac.
We did not find any studies that compared different routes of administration of ibuprofen.
What are the limitations of the evidence?
We are uncertain about the overall evidence of ibuprofen use in postoperative pain in children, primarily because there were not enough large studies to be certain about any differences in ibuprofen when compared to other alternatives. In addition, only a few of the studies provided data about important benefits and unwanted effects for children experiencing pain following surgery, especially in the longer term.
How up to date is this evidence?
The evidence is up-to-date to August 2023.
Despite identifying 43 RCTs, we remain uncertain about the effect of ibuprofen compared to placebo or active comparators for some critical outcomes and in the comparisons between different doses, schedules and routes for ibuprofen administration. This is largely due to poor reporting on important outcomes such as serious adverse events, and poor study conduct or reporting that reduced our confidence in the results, along with small underpowered studies.
Compared to placebo, ibuprofen likely results in pain reduction less than two hours postintervention, however, the efficacy might be lower at two hours to 24 hours. Compared to paracetamol, ibuprofen likely results in pain reduction up to 24 hours postintervention. We could not explore if there was a different effect in different kinds of surgeries or procedures.
Ibuprofen likely results in a reduction in adverse events compared to morphine, and in little to no difference in bleeding when compared to paracetamol. We remain mostly uncertain about the safety of ibuprofen compared to other drugs.
Children often require pain management following surgery to avoid suffering. Effective pain management has consequences for healing time and quality of life. Ibuprofen, a frequently used non-steroidal anti-inflammatory drug (NSAID) administered to children, is used to treat pain and inflammation in the postoperative period.
1) To assess the efficacy and safety of ibuprofen (any dose) for acute postoperative pain management in children compared with placebo or other active comparators. 2) To compare ibuprofen administered at different doses, routes (e.g. oral, intravenous, etc.), or strategies (e.g. as needed versus as scheduled).
We used standard Cochrane search methods. We searched CENTRAL, MEDLINE, Embase, CINAHL and trials registries in August 2023.
We included randomised controlled trials (RCTs) in children aged 17 years and younger, treated for acute postoperative or postprocedural pain, that compared ibuprofen to placebo or any active comparator. We included RCTs that compared different administration routes, doses of ibuprofen and schedules.
We adhered to standard Cochrane methods for data collection and analysis. Our primary outcomes were pain relief reported by the child, pain intensity reported by the child, adverse events, and serious adverse events. We present results using risk ratios (RR) and standardised mean differences (SMD), with the associated confidence intervals (CI). We used GRADE to assess the certainty of the evidence.
We included 43 RCTs that enroled 4265 children (3935 children included in this review). We rated the overall risk of bias at the study level as high or unclear for 37 studies that had one or several unclear or high risk of bias judgements across the domains. We judged six studies as having a low risk of bias across all domains.
Ibuprofen versus placebo (35 RCTs)
No studies reported pain relief reported by the child or a third party, or serious adverse events. Ibuprofen probably reduces child-reported pain intensity less than two hours postintervention compared to placebo (SMD −1.12, 95% CI −1.39 to −0.86; 3 studies, 259 children; moderate-certainty evidence). Ibuprofen may reduce child-reported pain intensity, two hours to less than 24 hours postintervention (SMD −1.01, 95% CI −1.24 to −0.78; 5 studies, 345 children; low-certainty evidence). Ibuprofen may result in little to no difference in adverse events compared to placebo (RR 0.79, 95% CI 0.51 to 1.23; 5 studies, 384 children; low-certainty evidence).
Ibuprofen versus paracetamol (21 RCTs)
No studies reported pain relief reported by the child or a third party, or serious adverse events. Ibuprofen likely reduces child-reported pain intensity less than two hours postintervention compared to paracetamol (SMD −0.42, 95% CI −0.82 to −0.02; 2 studies, 100 children; moderate-certainty evidence). Ibuprofen may slightly reduce child-reported pain intensity two hours to 24 hours postintervention (SMD −0.21, 95% CI −0.40 to −0.02; 6 studies, 422 children; low-certainty evidence). Ibuprofen may result in little to no difference in adverse events (0 events in each group; 1 study, 44 children; low-certainty evidence).
Ibuprofen versus morphine (1 RCT)
No studies reported pain relief or pain intensity reported by the child or a third party, or serious adverse events. Ibuprofen likely results in a reduction in adverse events compared to morphine (RR 0.58, 95% CI 0.40 to 0.83; risk difference (RD) −0.25, 95% CI −0.40 to −0.09; number needed to treat for an additional beneficial outcome (NNTB) 4; 1 study, 154 children; moderate-certainty evidence).
Ibuprofen versus ketorolac (1 RCT)
No studies reported pain relief or pain intensity reported by the child, or serious adverse events. Ibuprofen may result in a reduction in adverse events compared to ketorolac (RR 0.51, 95% CI 0.27 to 0.96; RD −0.29, 95% CI −0.53 to −0.04; NNTB 4; 1 study, 59 children; low-certainty evidence).