IBUPAP Study for Pain Management in Children

IBUPAP - Combination of Oral Ibuprofen and Acetaminophen (APAP) is Superior to Either Analgesic Alone for Pediatric Emergency Department (ED) Patients With Acute Pain

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.

Study Overview

• Status: Completed
• Conditions: Pain Management
• Intervention / Treatment: Drug: Ibuprofen; Drug: APAP

Detailed Description

The investigators' hypothesize the combination of oral ibuprofen and acetaminophen (APAP) is superior to either analgesic alone plus placebo for pediatric emergency department patients with acute traumatic/non-traumatic pain

1. Intent to Treat, prospective, randomized, double-blind trial.

2. Primary outcome: Pain reduction via NRS/FACES pain scale at times 0 and 60 minutes from administration of medication(s).

   Secondary outcomes: Antipyretic effects, level of analgesia achieved with each patient diagnosis(es), incidence and type of adverse effect(s), and patients' and parents' satisfaction with achieved level of analgesia.

3. Population : ages 3 - 17. Sample size 90 patients (30 per arm). Group 1: oral ibuprofen at 10mg/kg dose and placebo of equal volume; Group 2: oral APAP at 15 mg/kg dose and placebo of equal volume; and, Group 3: oral ibuprofen at 10 mg/kg dose and APAP at 15mg/kg dose.
4. Location: Urban tertiary care hospital Pediatric ED with 40,000 annual departmental visits.
5. Duration of Enrollment: 1 year from commencement of the study.

6/7. Patients will be enrolled and randomized upon triage by an assigned nurse dedicated to the study into one of three groups by using a blocks-randomization scheme for every 15 patients maintained by the ED pharmacists.

8. For patients experiencing breakthrough pain, oral morphine sulfate at 0.2mg/kg will be provided.

Group 1: oral ibuprofen at 10 mg/kg dose and placebo of equal volume;

Group 2: oral APAP at 15 mg/kg dose and placebo of equal volume; and,

Group 3: oral ibuprofen at 10 mg/kg dose and APAP at 15mg/kg dose. Medications including placebo will be given via prefilled syringes of identical volume, color and flavor. Level of analgesia will be assessed at times 0 and 60 minutes from administration of medication(s).

All enrolled patients, health care practitioners, and research associates will be blinded to the study medication(s) given and to the allocation sequence. Pharmacist(s) who are aware of the study medication(s) will not enroll patients. The allocation sequence code will only be revealed to the researchers once recruitment, data collection, and data entry are completed.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Oral Ibuprofen; Oral Ibuprofen at 10mg/kg dose and placebo of equal volume	Drug: Ibuprofen; Oral Ibuprofen at 10 mg/kg dose
ACTIVE_COMPARATOR: Oral APAP; Oral APAP at 15 mg/kg and placebo of equal volume	Drug: APAP; Oral APAP at 15mg/kg dose
ACTIVE_COMPARATOR: Oral Ibuprofen and Oral APAP; Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose.	Drug: Ibuprofen; Oral Ibuprofen at 10 mg/kg dose; Drug: APAP; Oral APAP at 15mg/kg dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Antonios Likourezos

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 30, 2018
• Primary Completion (ACTUAL): October 31, 2019
• Study Completion (ACTUAL): July 30, 2020

Study Registration Dates

• First Submitted: March 18, 2017
• First Submitted That Met QC Criteria: March 18, 2017
• First Posted (ACTUAL): March 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 2017-01-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No