Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia

Phase 4

Not yet recruiting

• Conditions: Pain, Postoperative; Pediatric Dental Surgery
• Interventions: Drug: Ibuprofen; Drug: Acetominophen

• Registration Number: NCT06757075
• Lead Sponsor: Boston University

Brief Summary

The purpose of this study is to investigate the effectiveness of various oral analgesic regimens in minimizing post-operative pain and discomfort in young children following dental rehabilitation under general anesthesia (DRGA). In this randomized controlled trial, three analgesic regimens following DRGA in Franciscan Children's Hospital will be compared using both self-report and behavioral measures.

The analgesic therapies to be investigated are ibuprofen monotherapy, alternating ibuprofen and acetaminophen dual-therapy, and combined ibuprofen and acetaminophen dual-therapy. For the purposes of this study, combined therapy is defined as the simultaneous administration of acetaminophen and ibuprofen at regular intervals, whereas alternating therapy is defined as one analgesic (acetaminophen or ibuprofen) administered within a 3 hour interval of the other.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2024-12-24
• Last Update Submitted: 2024-12-24
• Study Start: 2025-01
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• American Society of Anesthesiologists (ASA) I-II
• Requiring Oral Rehabilitation under General Anesthesia
• Possess legal guardians proficient in English
• Not have a history of any adverse/allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) or Acetaminophen

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Exclusion Criteria

• ASA III or IV
• Asthma diagnosis
• Contraindication to acetaminophen or ibuprofen

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alternating analgesics	Ibuprofen	Participants randomized into this arm will be given alternating Ibuprofen and Acetaminophen every 6 hours, alternating the two medications every 3 hours: first dose ibuprofen, three hours later acetaminophen for 24 hours.
Alternating analgesics	Acetominophen	Participants randomized into this arm will be given alternating Ibuprofen and Acetaminophen every 6 hours, alternating the two medications every 3 hours: first dose ibuprofen, three hours later acetaminophen for 24 hours.
Simultaneous post-operative analgesics	Ibuprofen	Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours.
Simultaneous post-operative analgesics	Acetominophen	Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours.
Control Standard of Care	Ibuprofen	Participants randomized into this arm will be given Ibuprofen every 6 hours for 24 hours.

Primary Outcome Measures

Name	Time	Method
Dental discomfort assessed by the abbreviated DDQ-8	day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery	The Dental Discomfort Questionnaire (DDQ-8)-Abbreviated is an 8 item questionnaire completed by the caregiver. Responses to each question are Yes=2 and No=0 creating a possible range of total scores of 0-16 with higher scores correlated with more dental discomfort.
Pain assessment based on the FLACC	day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery	The Face, Legs, Activity, Cry, and Consolability (FLACC) scale assesses pain by the caregiver on 5 aspects of behavior: (F) facial expression; (L) leg movement; (A) activity; (C) cry; (C) consolability. Each behavior is rated 0 to 2 resulting in a range of scores from 0 to 10 with higher scores correlated with more pain.

Trial Locations

Locations (1)

Franciscan Children's Hospital; 🇺🇸 Brighton, Massachusetts, United States