IBUPAP Study for Pain Management in Children

• Sponsor: Antonios Likourezos (Other)
• Overall Status: Completed
• CT.gov ID: NCT03088800
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Actual Duration (Months): 27
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Management	Drug: Ibuprofen; Drug: APAP	Phase 2

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.

1. 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.

2. Location: Urban tertiary care hospital Pediatric ED with 40,000 annual departmental visits.

3. 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.

1. 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 Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: IBUPAP - Combination of Oral Ibuprofen and Acetaminophen (APAP) is Superior to Either Analgesic Alone for Pediatric Emergency Department (ED) Patients With Acute Pain
• Actual Study Start Date: Apr 30, 2018
• Actual Primary Completion Date: Oct 31, 2019
• Actual Study Completion Date: Jul 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain Score at 60 Minutes [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maimonides Medical Center	Brooklyn	New York	United States	11219

Sponsors and Collaborators

• Antonios Likourezos

Investigators

• Principal Investigator: Sergey Motov, MD, Maimonides Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 24, 2016

More Information

Publications

None provided.

• Responsible Party: Antonios Likourezos, Co-Investigator, Maimonides Medical Center
• ClinicalTrials.gov Identifier: NCT03088800
• Other Study ID Numbers: 2017-01-06
• First Posted: Mar 23, 2017
• Last Update Posted: Mar 25, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Ibuprofen

Study Results

Participant Flow

Arm/Group Title	Oral Ibuprofen	Oral APAP	Oral Ibuprofen and Oral APAP
Arm/Group Description	Oral Ibuprofen at 10mg/kg dose and placebo of equal volume Ibuprofen: Oral Ibuprofen at 10 mg/kg dose	Oral APAP at 15 mg/kg and placebo of equal volume APAP: Oral APAP at 15mg/kg dose	Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose. Ibuprofen: Oral Ibuprofen at 10 mg/kg dose APAP: Oral APAP at 15mg/kg dose
Period Title: Overall Study
STARTED	30	30	30
COMPLETED	30	30	30
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Oral Ibuprofen	Oral APAP	Oral Ibuprofen and Oral APAP	Total
Arm/Group Description	Oral Ibuprofen at 10mg/kg dose and placebo of equal volume Ibuprofen: Oral Ibuprofen at 10 mg/kg dose	Oral APAP at 15 mg/kg and placebo of equal volume APAP: Oral APAP at 15mg/kg dose	Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose. Ibuprofen: Oral Ibuprofen at 10 mg/kg dose APAP: Oral APAP at 15mg/kg dose	Total of all reporting groups
Overall Participants	30	30	30	90
Age (Count of Participants)
<=18 years	30 100%	30 100%	30 100%	90 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.20 (4.48)	10.90 (3.98)	12.17 (3.67)	11.42 (4.05)
Sex: Female, Male (Count of Participants)
Female	14 46.7%	9 30%	10 33.3%	33 36.7%
Male	16 53.3%	21 70%	20 66.7%	57 63.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	30 100%	30 100%	30 100%	90 100%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	30 100%	90 100%

Outcome Measures

1. Primary Outcome

Title	Pain Score at 60 Minutes
Description	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)
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Ibuprofen	Oral APAP	Oral Ibuprofen and Oral APAP
Arm/Group Description	Oral Ibuprofen at 10mg/kg dose and placebo of equal volume Ibuprofen: Oral Ibuprofen at 10 mg/kg dose	Oral APAP at 15 mg/kg and placebo of equal volume APAP: Oral APAP at 15mg/kg dose	Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose. Ibuprofen: Oral Ibuprofen at 10 mg/kg dose APAP: Oral APAP at 15mg/kg dose
Measure Participants	30	30	30
Mean (Standard Deviation) [units on a scale]	2.72 (2.15)	3.10 (1.92)	2.77 (2.08)

Adverse Events

Time Frame	60 minutes
Arm/Group Title	Oral Ibuprofen		Oral APAP		Oral Ibuprofen and Oral APAP
Arm/Group Description	Oral Ibuprofen at 10mg/kg dose and placebo of equal volume Ibuprofen: Oral Ibuprofen at 10 mg/kg dose		Oral APAP at 15 mg/kg and placebo of equal volume APAP: Oral APAP at 15mg/kg dose		Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose. Ibuprofen: Oral Ibuprofen at 10 mg/kg dose APAP: Oral APAP at 15mg/kg dose
All Cause Mortality
	Oral Ibuprofen		Oral APAP		Oral Ibuprofen and Oral APAP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)
Serious Adverse Events
	Oral Ibuprofen		Oral APAP		Oral Ibuprofen and Oral APAP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Oral Ibuprofen		Oral APAP		Oral Ibuprofen and Oral APAP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.