Drug Deemed Safe, Effective For Post-Surgical Pain In Children

Main Category: Pain / Anesthetics
Also Included In: Clinical Trials / Drug Trials
Article Date: 16 Oct 2009 - 2:00 PDT

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Parents and physicians alike want to know the best options for pain relief for children, especially following painful surgical procedures. A new review from Sweden finds that diclofenac a medication that works for some adults also relieves acute pain in children.

However, a U.S. researcher is not convinced that the review showed the alternate, costlier drug to be an improvement over standard pain-relief drugs, or that it is any safer for children.

A team led by Joseph Standing, a researcher in pharmaceutical biosciences at Uppsala University, looked at 86 studies: seven on the effectiveness of the drug diclofenac and 79 studies on its safety for the relief of pain in children.

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). Review studies compared diclofenac with either no treatment or a placebo; with paracetamol (acetaminophen); with other NSAIDS: nimesulide, tenoxicam or flurbiprofen; or with opioid drugs such as morphine.

The review appears in the latest issue of The Cochrane Library, a publication of the Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.

"Firstly, as in adults, we have shown diclofenac to be a very good analgesic for surgical pain," Standing said, "probably as good as standard doses of morphine, and without the nausea and vomiting."

"Secondly," he said, "it is truly a systematic review the first Cochrane review to look at adverse effects in such detail from such a range of studies, and to include all studies regardless of language." Standing said this has allowed the reviewers to assuage some of the fears about possible adverse events associated with diclofenac, such as kidney failure and bleeding after surgery.

The review discloses that Standing received a research grant from Rosemont Pharmaceuticals, a maker of diclofenac preparations, to undertake clinical safety and pharmacokinetic studies of the drug in children.

The researchers searched 17 databases in 2005, updating the search again in 2008, including a search of the World Health Organization (WHO) Monitoring Center. The review included all reports found in any language where patients who were 18 years old or younger received diclofenac for acute pain, and which included detailed safety or efficacy monitoring.

Amy Baxter, M.D., director of emergency research at the Children's Healthcare of Atlanta at Scottish Rite, noted that the studies reviewed included five comparisons of diclofenac to another NSAID, but the Cochrane review did not report on pain relief from any of these. Baxter said that the most important question, arguably, is, "If the stated study question is pain relief, how does a more expensive new drug compare to a standard well-studied one?"

"This study reveals that there is currently insufficient data to recommend changing current practice to diclofenac on a wide scale without further defining safety for asthmatic children, cost/benefit comparisons and [examining] diclofenac versus standard NSAIDs," Baxter added. "It appears diclofenac can be considered for use in children when clinical situations warrant an alternate or non-paracetamol pain reliever."

Baxter pointed out that the majority of papers compared pain relief of diclofenac to placebo or no treatment, and the comparison favoring diclofenac versus acetaminophen was non-significant and included only 107 patients from two papers.

The single comparison of diclofenac versus other NSAIDS found an increased, although non-significant of risk of bleeding for diclofenac. "It's leaning towards worse for diclofenac than for NSAIDs," Baxter said. "While it's technically not significant, the ratios are concerning.

Baxter and the review authors point out that the range of diclofenac doses in studies varied so much as to make comparisons difficult.

However, the reviewers did find that patients experienced less nausea, vomiting or both compared to other non-NSAIDs. The review did not find increased bleeding near the time of surgery that required additional surgery and found a rate of adverse reactions similar to that seen in adults.

As for safety concerns regarding children with asthma: "We did not find enough asthmatic patients exposed to diclofenac to judge whether fears that it worsens asthma are founded," Standing said.

Baxter said there is no evidence that diclofenac is safer than other NSAIDs and that there is some suggestion that it might make patients more prone to bleeding.

Standing disagrees. "For those anaesthetists and surgeons already using diclofenac, it will reassure them," he said. "For those who do not use diclofenac mainly due to fears of it causing more bleeding, which have now just been refuted in our Cochrane review some may introduce it, or another NSAID, into their practice."

The Cochrane Library contains high quality health care information, including Systematic Reviews from The Cochrane Collaboration. These reviews bring together research on the effects of health care and are considered the gold standard for determining the relative effectiveness of different interventions. The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions.

Source: Health Behavior News Service