drugset / Trial / NCT04476069

Ibuprofen as a Pain Management in Pediatric Dentistry

NCT04476069

Phase 3 Completed 56 enrolled Princess Nourah Bint Abdulrahman University
RandomizedParallel-groupTriple-blindPrevention

Summary

Abstract Introduction: Administration of non-steroidal anti-inflammatory drugs (NSAIDs) before tooth extraction may reduce post-surgical pain, but there is a lack of research. Aims: To compare pain and anxiety in pediatric tooth extraction patients receiving a preoperative NSAID vs. placebo. Design: Randomized, double-blind, placebo-controlled clinical trial. Setting: Princess Nourah Bint Abdulrahman University's (PNU's) dental clinic in Riyadh, Saudi Arabia. Materials and Methods: Eligible pediatric tooth extraction patients were randomized to Group A, which received NSAID preoperatively, or Group B, which received placebo. Interventions: A research coordinator (RC) measured participants prior to extraction, and 3- and 24-hours post-extraction. Main Outcome Methods: The Wong-Baker FACES scale (WBFS) and the Modified Child Dental Anxiety Scale - Faces (MCDASf).

Timeline

Start
2019-01-10
Primary completion
2019-03-28
Completion
2019-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibuprofen Small molecule 7.5 unknown Oral
Subject Ibuprofen Small molecule 15 unknown Oral

Indications

No indication recorded.