Managing pain in young children after dental surgery under anesthesia
A Comparison of Standard Dose of Ibuprofen Alone, Alternating, or Combined With Acetaminophen for the Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia
This study is testing which pain relief method works best for young children aged 4-6 after they have dental surgery under anesthesia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 4 Years to 6 Years |
| Sex | All |
| Sponsor | Boston University Academic / other |
| Locations | 1 site (Brighton, Massachusetts) |
| Trial ID | NCT06757075 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of different oral analgesic regimens to reduce postoperative pain in young children aged 4-6 years following dental rehabilitation under general anesthesia. It is a randomized controlled trial comparing three approaches: ibuprofen alone, alternating ibuprofen and acetaminophen, and a combined regimen of both medications. The study will utilize self-reporting and behavioral measures to assess pain levels and discomfort in participants. Conducted at Franciscan Children's Hospital, the trial aims to identify the most effective pain management strategy for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-6 years requiring dental rehabilitation under general anesthesia and who are classified as ASA I-II.
Not a fit: Patients with ASA III or IV classifications, asthma, or contraindications to acetaminophen or ibuprofen may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for young children undergoing dental procedures, enhancing their recovery experience.
How similar studies have performed: Other studies have shown varying success with similar analgesic regimens in pediatric populations, indicating potential for effective pain management strategies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Exclusion Criteria: * ASA III or IV * Asthma diagnosis * Contraindication to acetaminophen or ibuprofen
Where this trial is running
Brighton, Massachusetts
- Franciscan Children's Hospital — Brighton, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Keri Discepolo, DDS MPH — BU Goldman School of Dental Medicine, Pediatrics
- Study coordinator: Keri Discepolo, DDS MPH
- Email: kdiscep@bu.edu
- Phone: 617-358-3446
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.