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Ibuprofen Plus Acetaminophen for Enhanced Pain Reduction

NCT04630834 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-04-14

No results posted yet for this study

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.

Conditions

  • Pain, Acute

Interventions

DRUG

Ibuprofen

Patients will receive both ibuprofen 10mg/kg weight based dosing with a max of 600mg

DRUG

Acetaminophen

patients will receive acetaminophen 15 mg/kg weight based dosing with a max of 650mg

DRUG

Placebo

patients will receive placebo 15mg/kg weight based dosing with a max of 650mg

Sponsors & Collaborators

  • New York City Health and Hospitals Corporation

    lead OTHER

Principal Investigators

  • Sandra Cunningham, MD · NYCHHC - Jacobi Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-30
Primary Completion
2022-06-20
Completion
2022-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04630834 on ClinicalTrials.gov