Ibuprofen Plus Acetaminophen for Enhanced Pain Reduction

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Combination of analgesics with different modes of action have the potential to offer enhanced pain relief with reduced dosage. Ibuprofen and acetaminophen have different modes of action. Combination of ibuprofen and acetaminophen has shown enhanced analgesia in adult studies, with pediatric data limited to post-operative pain and dental pain. Our study objective is to evaluate the analgesic efficacy of oral acetaminophen plus ibuprofen versus ibuprofen plus placebo for the management of acute pain in a pediatric emergency department.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York City Health and Hospitals Corporation
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• Patients with a numeric pain score of greater than or equal to 5 or Wong -Baker FACES Pain Scale of greater than or equal to 6

Exclusion Criteria:

• known allergy to ibuprofen

• Known allergy to acetaminophen

• documented or suspected pregnancy

• inability to tolerate oral medication

• a contraindication to oral intake

• inability to reliably indicate a pain score

• intake of ibuprofen or acetaminophen less than 4 hours prior to presentation

• inability to communicate in Spanish or English

• the need for immediate parenteral pain medication as per the treating physician.