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Ibuprofen as a Pain Management in Pediatric Dentistry

NCT04476069 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-07-17

No results posted yet for this study

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).

Conditions

  • Pain Management

Interventions

DRUG

IBUPROFEN

given to children 30 minutes before extraction / orally for one time only

Sponsors & Collaborators

  • Princess Nourah Bint Abdulrahman University

    lead OTHER

Principal Investigators

  • Abeer A Alshami, PhD · Princess Noura Bint Abdulrhman University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Saudi Arabia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04476069 on ClinicalTrials.gov