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NCT04476069

Ibuprofen as a Pain Management in Pediatric Dentistry

Completed Phase 3 Last updated 17 July 2020
What this trial tests

Phase 3 trial testing IBUPROFEN in Pain Management in 56 participants. Completed in 30 May 2019.

Timeline
10 January 2019
Primary endpoint
28 March 2019
30 May 2019

Quick facts

Lead sponsorPrincess Nourah Bint Abdulrahman University
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment56
Start date10 January 2019
Primary completion28 March 2019
Estimated completion30 May 2019
Sites1 location across Saudi Arabia

Drugs / interventions tested

Conditions studied

Sponsor

Princess Nourah Bint Abdulrahman University

Who can join

Adults 5 to 13, any sex, with Pain Management. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Ibuprofen for acute postoperative pain in children.
    Pessano S, Gloeck NR, Tancredi L, Ringsten M, et al · · 2024 · cited 7× · PMID 38180091 · DOI 10.1002/14651858.cd015432.pub2

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