J. Orthod.
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Journal of Orthodontics, Vol. 32, No. 3, 203-205, September 2005 doi:10.1179/146531205225021105
© 2005 British Orthodontic Society
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Scientific Section

Report of an adverse incident in a randomized clinical trial

Rebecca L McAlinden and Pamela E Ellis

Dorset County Hospital and Bristol University, Bristol, UK

Jonathan R. Sandy

Unit of Child Dental Health, Bristol University, Bristol, UK

Address for correspondence: Miss R. L. McAlinden, Orthodontic Department, Dorset County Hospital, Williams Avenue, Dorchester, Dorset DT1 2JY, UK. Email: Rebecca.McAlinden{at}wdgh.nhs.uk

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.

Key words: Adverse reaction, clinical trial, orthodontics, paracetamol






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