Ibuprofen Plus Acetaminophen for Enhanced Pain Reduction

NCT04630834 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 2020-12329
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

children

Outcome Measures

Primary Outcomes (1)

• Pain score

  Change in mean pain score from baseline pain score. A validated pain score for children beginning at 3 years old, the Wong-Baker FACES pain scale (0-10 scale), will be used for patients ages 3 through 7 years. A validated numeric pain score (0-10 scale) will be used for patients 8 through 20 years. The higher score indicate worse pain.

  1 hour and 2 hours

Secondary Outcomes (1)

• Number of participants requiring rescue medications.

  1 hour and 2 hours

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Drug: Ibuprofen; Drug: Acetaminophen

Placebo Group

PLACEBO COMPARATOR

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

Drug: Ibuprofen; Drug: Placebo

Interventions

Ibuprofen DRUG

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

Intervention group; Placebo Group

Acetaminophen DRUG

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

Intervention group

Placebo DRUG

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

Placebo Group

Eligibility Criteria

• Age: 3 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Related Publications (6)

• Poddighe D, Brambilla I, Licari A, Marseglia GL. Ibuprofen for Pain Control in Children: New Value for an Old Molecule. Pediatr Emerg Care. 2019 Jun;35(6):448-453. doi: 10.1097/PEC.0000000000001505.

  PMID: 29912084 BACKGROUND

• Gaglani A, Gross T. Pediatric Pain Management. Emerg Med Clin North Am. 2018 May;36(2):323-334. doi: 10.1016/j.emc.2017.12.002.

  PMID: 29622325 BACKGROUND

• Jozwiak-Bebenista M, Nowak JZ. Paracetamol: mechanism of action, applications and safety concern. Acta Pol Pharm. 2014 Jan-Feb;71(1):11-23.

  PMID: 24779190 BACKGROUND

• Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.

  PMID: 20142348 BACKGROUND

• Gazal G, Mackie IC. A comparison of paracetamol, ibuprofen or their combination for pain relief following extractions in children under general anaesthesia: a randomized controlled trial. Int J Paediatr Dent. 2007 May;17(3):169-77. doi: 10.1111/j.1365-263X.2006.00806.x.

  PMID: 17397460 BACKGROUND

• Motov S, Butt M, Masoudi A, Palacios W, Fassassi C, Drapkin J, Likourezos A, Hossain R, Brady J, Rothberger N, Flom P, Zerzan J, Marshall J. Comparison of Oral Ibuprofen and Acetaminophen with Either Analgesic Alone for Pediatric Emergency Department Patients with Acute Pain. J Emerg Med. 2020 May;58(5):725-732. doi: 10.1016/j.jemermed.2020.02.010. Epub 2020 Apr 1.

  PMID: 32247660 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Sandra Cunningham, MD

  NYCHHC - Jacobi Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Cunningham, MD

CONTACT

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

Jackeline Urrutia-Monteleone, MD

CONTACT

718-918-5875; urrutiaj@nychhc.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director, Pediatric Emergency Medicine

Model Details: Two arms will be run in parallel. One arm will be acetaminophen and ibuprofen combined. The other arm will be ibuprofen alone with a placebo.

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 16, 2020
• Study Start: March 30, 2021
• Primary Completion: June 20, 2022
• Study Completion: June 30, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)