Analgesic effectiveness, pharmacokinetics, and safety of a paracetamol/ibuprofen fixed-dose combination in children undergoing adenotonsillectomy: A randomized, single-blind, parallel group trial.

Show simple item record Playne, Rebecca en Anderson, Brian en Frampton, Chris en Stanescu, Ioana en Atkinson, Hartley C en 2019-03-08T02:28:01Z en 2018-12 en
dc.identifier.issn 1155-5645 en
dc.identifier.uri en
dc.description.abstract BACKGROUND:Pain following tonsillectomy is often poorly managed in the home setting. Multimodal analgesia with acetaminophen (paracetamol) and nonsteroidal anti-inflammatory drugs offers superior analgesia over monotherapy but may be difficult for caregivers to manage. A fixed-dose combination oral suspension product containing paracetamol and ibuprofen has been developed to facilitate pediatric dosing. AIMS:The aims of this study are to determine the analgesic effectiveness, pharmacokinetics, and safety of the fixed-dose combination at two doses in the pediatric population. METHODS:In this prospective, multicenter, randomized, single-blind, parallel group trial, 251 children aged 2-12 years undergoing day-stay (adeno)tonsillectomy were randomized to two dose groups of the fixed-dose combination. A doubled loading dose was given preoperatively, followed by treatment for up to 11 days (Higher dose: paracetamol 15 mg/kg + ibuprofen 4.5 mg/kg, Lower dose: paracetamol 12 mg/kg + ibuprofen 3.6 mg/kg). Blood samples were collected for pharmacokinetic analysis for up to 6 hours after the loading dose. The analgesic effectiveness was examined on the first day after surgery using both Parents Postoperative Pain Measurement and modified Wong-Baker Faces pain scales. Rescue medication consumption was recorded throughout the study. RESULTS:Differences in maximum plasma concentration (Cmax ) and total exposure (AUC0→t ) between the treatment groups for both analytes were consistent with a 25% increase in dose; there was no difference in time to peak concentration (Tmax ). On the first postoperative day, there was no difference in pain scores or rescue medication use between treatment groups (approximately 30% in both groups). The combination was well tolerated by both groups. The most common adverse events were vomiting and nausea. The incidence of postoperative bleeding was 4.4%. CONCLUSION:The shallow dose-response relationship and good tolerability of the fixed-dose combination over an extended study period supports the utility of both doses of the fixed-dose combination in the home setting. en
dc.format.medium Print-Electronic en
dc.language eng en
dc.relation.ispartofseries Paediatric anaesthesia en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. en
dc.rights.uri en
dc.subject Humans en
dc.subject Pain, Postoperative en
dc.subject Acetaminophen en
dc.subject Ibuprofen en
dc.subject Analgesics, Non-Narcotic en
dc.subject Pain Measurement en
dc.subject Drug Therapy, Combination en
dc.subject Adenoidectomy en
dc.subject Tonsillectomy en
dc.subject Prospective Studies en
dc.subject Single-Blind Method en
dc.subject Child en
dc.subject Child, Preschool en
dc.subject Female en
dc.subject Male en
dc.subject Kaplan-Meier Estimate en
dc.title Analgesic effectiveness, pharmacokinetics, and safety of a paracetamol/ibuprofen fixed-dose combination in children undergoing adenotonsillectomy: A randomized, single-blind, parallel group trial. en
dc.type Journal Article en
dc.identifier.doi 10.1111/pan.13517 en
pubs.issue 12 en
pubs.begin-page 1087 en
pubs.volume 28 en
dc.rights.holder Copyright: The author en
pubs.end-page 1095 en
pubs.publication-status Published en
dc.rights.accessrights en
pubs.subtype Research Support, Non-U.S. Gov't en
pubs.subtype Multicenter Study en
pubs.subtype Randomized Controlled Trial en
pubs.subtype Journal Article en
pubs.elements-id 756086 en Medical and Health Sciences en School of Medicine en Anaesthesiology en
dc.identifier.eissn 1460-9592 en
pubs.record-created-at-source-date 2018-10-31 en
pubs.dimensions-id 30375109 en

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