Evaluating the Efficacy of a Single Preemptive Dose of Ketorolac and Paracetamol for Managing Orthodontic Procedure Pain in Adolescents: A Randomized Controlled Trial

Orthodontic Treatment, while aiming for aesthetically pleasing outcomes, frequently induces orofacial pain and discomfort in patients. There are various methods for the management of pain caused by orthodontic procedures such as nonsteroidal anti-inflammatory drugs (NSAIDs). This study aims to evaluate the efficacy of a single preemptive dose of ketorolac and paracetamol in managing pain associated with orthodontic procedures in adolescents. This crossover clinical trial study will be double-blinded and will be conducted on randomly selected 150 adolescents who are undergoing fixed orthodontic treatment. Each patient will randomly receive three different drugs (Ketorol 10 mg, Paracetamol 500 mg, and placebo or Lactose) at separate appointments, with a one-month interval between each administration. The masking of the drugs will be done by packing them in separate, identical-looking packets labeled with the patient’s name. Patients and investigators will be unaware of the content of the tablets (double blinding) received until the end of the study. This helps to reduce bias in the results. During the 1st appointment, the patient will be trained on how to record his pain perception on the visual analog scale after the orthodontic procedure. After that at each stage, patients will be prescribed a single preemptive dose, 1 hour before the archwire activation. Each patient will thereafter be asked to note the degree of pain perceived at specific intervals of time (immediately after the procedure, 6 hours, 24 hours, 48 hours) on the 100-mm visual analog scale (VAS). Intraprocedural pain will be recorded immediately after the completion of the procedure. Postprocedural pain will be assessed at 6 hours, 24 hours, and 48 hours after the orthodontic treatment. In each level, questionnaires will be collected and the effects of three drugs will be compared.