Report of an adverse incident in a randomized clinical trial.
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.
McAlinden
Rebecca L
RL
Dorset County Hospital and Bristol University, UK. Rebecca.McAlinden@wdgh.nhs.uk
Ellis
Pamela E
PE
Sandy
Jonathan R
JR
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
D018712:Analgesics, Non-Narcotic; D000082:Acetaminophen