Recruiting

Ibuprofen & Acetaminophen

Sponsor:

New York City Health and Hospitals Corporation

Code:

NCT04630834

Conditions

Pain, Acute

Eligibility Criteria

Sex: All

Age: 3 - 20

Healthy Volunteers: Accepted

Interventions

Ibuprofen

Acetaminophen

Placebo

Study Details

Brief 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

Study ID

NCT04630834

Start date

Mar 30, 2021

Status verified date

Apr, 2022

Completion date

Jun 30, 2022

Anticipated

Primary completion date

Jun 20, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 20

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intervention group

Intervention Group: ibuprofen 10 mg/kg (maximum 600mg) plus acetaminophen 15mg/kg (maximum 650mg)

placebo comparator: Placebo Group

Placebo Group: Ibuprofen 10mg/kg (maximum 600 mg) plus placebo 15mg/kg (maximum 650mg)

Interventions

Ibuprofen

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

Acetaminophen

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

Placebo

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

Primary outcome measure

  • Pain score [ Time Frame: 1 hour and 2 hours ]

Central Contacts and Locations

Central contacts

Sandra Cunningham, MD

718-918-5875sandra.cunningham@nychhc.org

Jackeline Urrutia-Monteleone, MD

718-918-5875urrutiaj@nychhc.org

Locations

Jacobi Medical Center

Recruiting

Bronx, New York, United States, 10461

Contacts

Sandra Cunningham, MD

718-918-5875sandra.cunningham@nbhn.net

More Information

Sponsor

New York City Health and Hospitals Corporation

Last update posted

Apr 14, 2022

Last verified

Apr, 2022

Keywords

  • children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York City Health and Hospitals Corporation on 2022-04-14.