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.

RCT Entities:   Population Interventions Outcomes