IBUPAP Study for Pain Management in Children

NCT ID: NCT03088800

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2020-07-30

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.

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.

Conditions

Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral Ibuprofen

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

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

Oral Ibuprofen at 10 mg/kg dose

Oral APAP

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

Group Type: ACTIVE_COMPARATOR

APAP

Intervention Type: DRUG

Oral APAP at 15mg/kg dose

Oral Ibuprofen and Oral APAP

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

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

Oral Ibuprofen at 10 mg/kg dose

APAP

Intervention Type: DRUG

Oral APAP at 15mg/kg dose

Interventions

Ibuprofen

Oral Ibuprofen at 10 mg/kg dose

Intervention Type: DRUG

APAP

Oral APAP at 15mg/kg dose

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antonios Likourezos

OTHER

Sponsor Role: lead

Responsible Party

Antonios Likourezos

Co-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sergey Motov, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

Maimonides Medical Center

Brooklyn, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-01-06

Identifier Type: -

Identifier Source: org_study_id