Ibuprofen + Acetaminophen for Postoperative Pain

Recruiting in Palo Alto (17 mi)

Overseen byKeri Discepolo, DDS MPH

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Boston University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Keri Discepolo, DDS MPH

Principal Investigator

BU Goldman School of Dental Medicine, Pediatrics

Eligibility Criteria

This trial is for young children who have undergone dental rehabilitation under general anesthesia and need pain management. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.

Inclusion Criteria

Not have a history of any adverse/allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) or Acetaminophen

Possess legal guardians proficient in English

I am in good or mild systemic disease state according to ASA.

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Exclusion Criteria

I have a serious health condition but am not at immediate risk of death.

I cannot take acetaminophen or ibuprofen due to health reasons.

I have been diagnosed with asthma.

Treatment Details

Interventions

Acetaminophen (Analgesic)
Ibuprofen (Nonsteroidal Anti-Inflammatory Drug)

Trial OverviewThe study is testing three different ways to manage pain in kids after dental surgery: just ibuprofen, switching between ibuprofen and acetaminophen, or giving both at regular times. It's a randomized controlled trial at Franciscan Children's Hospital.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Simultaneous post-operative analgesicsExperimental Treatment2 Interventions

Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours.

Group II: Alternating analgesicsExperimental Treatment2 Interventions

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.

Group III: Control Standard of CareActive Control1 Intervention

Participants randomized into this arm will be given Ibuprofen every 6 hours for 24 hours.