IBUPAP Study for Pain Management in Children

NCT03088800 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2017-01-06
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Current literature supports ibuprofen and APAP are the most commonly used analgesics in the pediatric ED for acute traumatic/non-traumatic pain. However, the analgesic benefits of combination ibuprofen and APAP in this specific setting does not exist, but instead only as it applies to pediatric patients with postoperative pain. Thus, we have designed a double-blind, randomized, controlled clinical trial to evaluate analgesic efficacy, safety and feasibility of combination therapy to potentially broaden its clinical application in the pediatric ED. The investigators' hypothesize that combination oral ibuprofen and APAP therapy is superior to either drug alone and is an excellent analgesic modality for controlling acute traumatic/non-traumatic pain in the pediatric ED.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• Pain Score at 60 Minutes

  Pain Score via Numeric Rating Scale or FACES pain scale at 60 minutes from baseline ( ranging from 0 to 10, with 0 being no pain, 5 being moderate pain, and 10 being very severe pain)

  60 minutes

Study Arms (3)

Oral Ibuprofen

ACTIVE COMPARATOR

Oral Ibuprofen at 10mg/kg dose and placebo of equal volume

Drug: Ibuprofen

Oral APAP

ACTIVE COMPARATOR

Oral APAP at 15 mg/kg and placebo of equal volume

Drug: APAP

Oral Ibuprofen and Oral APAP

ACTIVE COMPARATOR

Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose.

Drug: Ibuprofen; Drug: APAP

Interventions

Ibuprofen DRUG

Oral Ibuprofen at 10 mg/kg dose

Oral Ibuprofen; Oral Ibuprofen and Oral APAP

APAP DRUG

Oral APAP at 15mg/kg dose

Oral APAP; Oral Ibuprofen and Oral APAP

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ages 3-17 years old presenting to the pediatric ED
• treating physician deems patient required ibuprofen Tylenol or both for pain relief

You may not qualify if:

• documented or suspected pregnancy, (2)
• parental refusal,
• allergies to NSAIDS or APAP
• inability to tolerate oral medications or contraindications to oral medication route
• received analgesics within 4 hours prior to ED presentation
• inability to use pain scales

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sergey Motov, MD
• Organization: Maimonides Medical Center

smotov@maimonidesmed.org

7182836000

Study Officials

• Sergey Motov, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: March 18, 2017
• First Posted: March 23, 2017
• Study Start: April 30, 2018
• Primary Completion: October 31, 2019
• Study Completion: July 30, 2020
• Last Updated: March 25, 2021
• Results First Posted: March 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)