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Diclofenac for acute pain in children
Joseph F Standing1, Imogen Savage, Deborah Pritchard
1Pharmaceutical Biosciences, Uppsala Universitet, Division of Pharmacokinetics and Drug Therapy, Uppsala Universistet BMC Box 591, Uppsala, Sweden, 75124.
Insights
Diclofenac effectively manages acute pain in children, reducing the need for rescue analgesia and decreasing nausea/vomiting. Serious adverse reactions are rare and similar to those in adults, though more research on dosing and asthmatic children is needed.
Area of Science:
- Pediatric Pharmacology
- Pain Management
- Evidence-Based Medicine
Background:
- Diclofenac is widely used for acute pain in pediatric populations.
- Its use is not universally licensed across all pediatric age groups for this indication.
Purpose of the Study:
- To evaluate the efficacy of diclofenac for treating acute pain in children.
- To assess the safety profile of short-term diclofenac administration in pediatric patients.
- To identify evidence gaps for future research directions.
Main Methods:
- A comprehensive search of 17 databases for clinical trial reports was conducted.
- Adverse reaction data from the UK Yellow Card Scheme and WHO were reviewed.
- Included studies involved pediatric patients (≤18 years) with acute pain, assessing efficacy or safety.
Main Results:
- Diclofenac significantly reduced the need for rescue analgesia compared to placebo (NNT 3.6).
- It was associated with less nausea or vomiting compared to non-NSAID treatments (NNT 7.7).
- Serious adverse reactions were infrequent (<0.24%) and comparable to adult profiles.
Conclusions:
- Diclofenac demonstrates efficacy as an analgesic for perioperative acute pain in children.
- Serious adverse reactions in children are rare and similar to those observed in adults.
- Further research is recommended for optimal dosing and safety in pediatric patients, particularly those with asthma.
Background:
Diclofenac is commonly used for acute pain in children, but is not licensed for this indication in all age groups.
Objectives:
1) Assess the efficacy of diclofenac for acute pain in children. 2) Assess the safety of diclofenac for short-term use in children. 3) Identify gaps in the evidence to direct future research.
Search Strategy:
Seventeen databases indexing clinical trial reports were searched in February 2005 (with an update search as part of this first review in May 2008). A hand search of Paediatric Anaesthesia was undertaken and summaries obtained of adverse reaction reports from the UK Yellow Card Scheme and World Health Organization (WHO) Monitoring Centre. The reference lists of included studies were also searched.
Selection Criteria:
Any published report, in any language, involving the administration of diclofenac to a patient aged 18 years or younger for acute pain and detailing either monitoring of efficacy or safety.
Data Collection And Analysis:
Two review authors independently assessed study quality and extracted the data. Authors were contacted where necessary. Review Manager version 5 was used for analysis.
Main Results:
1) EFFICACY: randomised controlled trials (RCTs) comparing diclofenac with placebo/any other treatment by using pain scores (assessed or reported), or need for rescue analgesia.2) SAFETY: any type of study seeking adverse events (regardless of cause). An adverse event was defined as any reported adverse or untoward happening to a patient being treated with diclofenac for acute pain.Seven publications on diclofenac efficacy and 79 on safety (74 studies plus five case reports) were included in the final analysis. Compared with placebo/no treatment, diclofenac significantly reduced need for post-operative rescue analgesia (relative risk [RR] 0.6; number needed to treat to benefit [NNT] 3.6; 95% confidence interval [CI] 2.5 to 6.3).Compared with any other non-NSAID, patients receiving diclofenac suffered less nausea or vomiting, or both (RR 0.6; NNT 7.7 [5.3 to 14.3]). There appeared to be no increase in bleeding requiring surgical intervention in patients receiving diclofenac in the peri-operative period. Serious diclofenac adverse reactions occurred in fewer than 0.24% of children treated for acute pain. The types of serious adverse reactions were similar to those reported in adults.
Authors' Conclusions:
Diclofenac is an effective analgesic for perioperative acute pain in children. It causes similar types of serious adverse reactions in children as in adults, but these are rare. More research on optimum dosing and safety in asthmatic children is required.
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