Diclofenac and metabolite pharmacokinetics in children

Marel, C. D. van der; Anderson, Brian J.; Rømsing, Janne; Jacqz-Aigrain, Évelyne; Tibboel, Dick

doi:10.1111/j.1460-9592.2004.01232.x

Cited by 74 publications

(15 citation statements)

References 37 publications

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“…The NSAID diclofenac is commonly prescribed for postoperative analgesia in children, yet its dosing in this patient group remains largely dependent on extrapolation from adult data . Although diclofenac PK in children have been reported , PD for analgesia have not. A pooled data analysis approach was used in this analysis to develop a PD interaction model for diclofenac in combination with acetaminophen for analgesia in children.…”

Section: Discussionmentioning

confidence: 99%

Postoperative analgesia using diclofenac and acetaminophen in children

Hannam

Anderson

Mahadevan

et al. 2014

Pediatric Anesthesia

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Section: Discussionmentioning

confidence: 99%

Postoperative analgesia using diclofenac and acetaminophen in children

Hannam

Anderson

Mahadevan

et al. 2014

Pediatric Anesthesia

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“…The rectal route was selected on the basis of available pilot data suggesting that only rectal NSAIDs are effective in preventing post-ERCP pancreatitis, perhaps owing to more rapid and complete bioavailability than with oral administration. 10,18 The indomethacin suppositories were purchased from two vendors: G&W Laboratories and Custom Med Apothecary. Formal potency testing confirmed that the vendors provided indomethacin suppositories that were pharmacodynamically equivalent (Analytic Research Laboratories).…”

Section: Methodsmentioning

confidence: 99%

A Randomized Trial of Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

et al. 2012

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Background Preliminary research suggests that rectally administered nonsteroidal antiinflammatory drugs may reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). Methods In this multicenter, randomized, placebo-controlled, double-blind clinical trial, we assigned patients at elevated risk for post-ERCP pancreatitis to receive a single dose of rectal indomethacin or placebo immediately after ERCP. Patients were determined to be at high risk on the basis of validated patient- and procedure-related risk factors. The primary outcome was post-ERCP pancreatitis, which was defined as new upper abdominal pain, an elevation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least 2 nights. Results A total of 602 patients were enrolled and completed follow-up. The majority of patients (82%) had a clinical suspicion of sphincter of Oddi dysfunction. Post-ERCP pancreatitis developed in 27 of 295 patients (9.2%) in the indomethacin group and in 52 of 307 patients (16.9%) in the placebo group (P = 0.005). Moderate-to-severe pancreatitis developed in 13 patients (4.4%) in the indomethacin group and in 27 patients (8.8%) in the placebo group (P = 0.03). Conclusions Among patients at high risk for post-ERCP pancreatitis, rectal indomethacin significantly reduced the incidence of the condition. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00820612.)

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“…Delayed-release diclofenac (enteric-coated), as used in this study, resists dissolution at the low pH of gastric fluids but is rapidly released in the higher pH environment of the duodenum. It is completely absorbed from the gastrointestinal tract after oral administration, but the bioavailability is only about 50% to 60% because of extensive first-pass metabolism, possibly as a result of intestinal cytochrome P450 (CYP2C9, 3A4, and 3A5) [41]. After the oral ingestion of diclofenac, peak plasma levels are reached in about 2 hours (range, 1 to 4) in fasting healthy volunteers; on the other hand, peak plasma levels with rectal administration are reached within 30 minutes [39].…”

Section: Results Of Pharmacological Approaches To Pepmentioning

confidence: 99%

Can postendoscopic retrograde cholangiopancreatography pancreatitis be prevented by a pharmacological approach?

Cheon

2013

Korean J Intern Med

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Acute pancreatitis remains the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP), with reported incidence rates that have changed little over several decades. Patient- and procedure-related risk factors for post-ERCP pancreatitis (PEP) are well-defined. Effective measures to prevent PEP have been identified, including improvements in cannulation techniques and pancreatic stenting, as well as pharmacological intervention. Pharmacotherapy has been widely studied in the prevention of PEP, but the effect in averting PEP has been inconclusive. Although pharmacological prophylaxis is appealing, attempts to find an ideal drug are incomplete. Most available data on the efficacy of pharmacological agents for PEP prophylaxis have been obtained from patients at average risk for PEP. However, recently, a randomized prospective controlled trial of rectal nonsteroidal anti-inflammatory drugs (NSAIDs) to prevent PEP in high-risk patients was published. The results revealed that rectal indomethacin reduced the incidence of PEP significantly. Thus, rectal administration of diclofenac or indomethacin immediately before or after ERCP is used routinely to prevent PEP. However, additional studies with NSAIDs using large numbers of subjects are necessary to confirm the prophylactic effect of these drugs and to establish whether they act synergistically with other prophylactic interventions, including pancreatic stenting.

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Diclofenac and metabolite pharmacokinetics in children

Cited by 74 publications

References 37 publications

Postoperative analgesia using diclofenac and acetaminophen in children

Postoperative analgesia using diclofenac and acetaminophen in children

A Randomized Trial of Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Can postendoscopic retrograde cholangiopancreatography pancreatitis be prevented by a pharmacological approach?

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