title: Report of an adverse incident in a randomized clinical trial.
abstract: This is a case report of a child who experienced a possible adverse reaction to paracetamol, in a randomized clinical trial comparing paracetamol with ibuprofen for control of orthodontic pain. Through this case report we highlight the importance of formulating a protocol for management of adverse events when designing a randomized clinical trial.
authors.affiliation: Dorset County Hospital and Bristol University, UK. Rebecca.McAlinden@wdgh.nhs.uk
authors.forename: Rebecca L
authors.initials: RL
authors.lastname: McAlinden
authors.forename: Pamela E
authors.initials: PE
authors.lastname: Ellis
authors.forename: Jonathan R
authors.initials: JR
authors.lastname: Sandy
mesh_terms: D000082:Acetaminophen / Q000009:adverse effects*; D016907:Adverse Drug Reaction Reporting Systems; D018712:Analgesics, Non-Narcotic / Q000009:adverse effects*; D002648:Child; D004342:Drug Hypersensitivity / Q000209:etiology*; D005189:False Positive Reactions; D006801:Humans; D008297:Male; D009967:Orthodontic Appliances / Q000009:adverse effects; D010146:Pain / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic
chemical_list: D018712:Analgesics, Non-Narcotic; D000082:Acetaminophen