Ibuprofen as a Pain Management in Pediatric Dentistry

NCT04476069 | Completed Phase 3 DMC

• 1 other identifier: H-01-R059
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• To compare pain and anxiety in pediatric tooth extraction patients receiving a preoperative NSAID vs. placebo

  Main Outcome Methods: measurement of the Wong Baker Faces (WBFS) scale has been used and patients assign a score of 0, 2, 4, 6, 8, and 10 to indicate their level of perceived pain. Score 10 is the highest level of pain

  First 24 hours after drug administration

Study Arms (2)

Ibuprofen

EXPERIMENTAL

30 minutes before extraction, once/day orally

Drug: IBUPROFEN

Placebo

PLACEBO COMPARATOR

30 minutes before extraction, once/day orally

Drug: IBUPROFEN

Interventions

IBUPROFEN DRUG

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

Ibuprofen; Placebo

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• child must be undergoing a simple extraction under local anesthesia of one or more symptomatic primary molars including teeth with pathology such as abscess, cyst, and internal resorption
• parent must provide consent and the child provide assent
• must not have any systematic disease
• must not be taking any medication that interacts with ibuprofen (the NSAID used in this study)
• must be cooperative
• Excluded Criteria Children were excluded for
• known allergy 2-having ever had an allergic reaction to ibuprofen 3- taking antibiotics or other medications 4-special needs due to a physical or mental disability 5-been given an analgesic prior to appointment by the guardian; 6-being treated for an emergency medical condition (e.g., cellulitis).

Sponsors & Collaborators

• Princess Nourah Bint Abdulrahman University: lead

Study Sites (1)

College of Dentistry /Princess Nourah Bint Abdulrhman University

Riyadh, 11671, Saudi Arabia

Location

Related Publications (2)

• Ashley PF, Parekh S, Moles DR, Anand P, MacDonald LC. Preoperative analgesics for additional pain relief in children and adolescents having dental treatment. Cochrane Database Syst Rev. 2016 Aug 8;2016(8):CD008392. doi: 10.1002/14651858.CD008392.pub3.

  PMID: 27501304 RESULT

• Al-Namankany A, de Souza M, Ashley P. Evidence-based dentistry: analysis of dental anxiety scales for children. Br Dent J. 2012 Mar 9;212(5):219-22. doi: 10.1038/sj.bdj.2012.174.

  PMID: 22402535 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Abeer A Alshami, PhD

  Princess Noura Bint Abdulrhman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: a professional research coordinator is hired to develop blinded materials. A list of identification numbers will be created, and each number will randomly be assigned to either Group A (receive ibuprofen prior to extraction) or Group B (receive placebo prior to extraction, as a control). Only the RC will know the assignment of the numbers to groups. Blinded medications will be developed and labelled according to the identification (ID) numbers. Once participants undergo consent, they will be assigned an ID number which placed them in a randomized group. The clinician will the medication associated with the participant's ID number prior to extraction.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor / Consultant in Pediatric dentistry

Model Details: Randomized, double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 17, 2020
• Study Start: January 10, 2019
• Primary Completion: March 28, 2019
• Study Completion: May 30, 2019
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

SA (1)