Trial Outcomes & Findings for IBUPAP Study for Pain Management in Children (NCT NCT03088800)

NCT ID: NCT03088800

Last Updated: 2021-03-25

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 90 participants
• Primary outcome timeframe: 60 minutes
• Results posted on: 2021-03-25

Participant Flow

Participant milestones

Measure	Oral Ibuprofen Oral Ibuprofen at 10mg/kg dose and placebo of equal volume Ibuprofen: Oral Ibuprofen at 10 mg/kg dose	Oral APAP Oral APAP at 15 mg/kg and placebo of equal volume APAP: Oral APAP at 15mg/kg dose	Oral Ibuprofen and Oral APAP 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
Overall Study STARTED	30	30	30
Overall Study COMPLETED	30	30	30
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IBUPAP Study for Pain Management in Children

Baseline characteristics by cohort

Measure	Oral Ibuprofen n=30 Participants Oral Ibuprofen at 10mg/kg dose and placebo of equal volume Ibuprofen: Oral Ibuprofen at 10 mg/kg dose	Oral APAP n=30 Participants Oral APAP at 15 mg/kg and placebo of equal volume APAP: Oral APAP at 15mg/kg dose	Oral Ibuprofen and Oral APAP n=30 Participants 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 n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	30 Participants n=5 Participants	30 Participants n=7 Participants	30 Participants n=5 Participants	90 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	11.20 years STANDARD_DEVIATION 4.48 • n=5 Participants	10.90 years STANDARD_DEVIATION 3.98 • n=7 Participants	12.17 years STANDARD_DEVIATION 3.67 • n=5 Participants	11.42 years STANDARD_DEVIATION 4.05 • n=4 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	33 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	57 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	30 Participants n=5 Participants	30 Participants n=7 Participants	30 Participants n=5 Participants	90 Participants n=4 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	30 participants n=5 Participants	90 participants n=4 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Oral Ibuprofen n=30 Participants Oral Ibuprofen at 10mg/kg dose and placebo of equal volume Ibuprofen: Oral Ibuprofen at 10 mg/kg dose	Oral APAP n=30 Participants Oral APAP at 15 mg/kg and placebo of equal volume APAP: Oral APAP at 15mg/kg dose	Oral Ibuprofen and Oral APAP n=30 Participants 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
Pain Score at 60 Minutes	2.72 units on a scale Standard Deviation 2.15	3.10 units on a scale Standard Deviation 1.92	2.77 units on a scale Standard Deviation 2.08

Adverse Events

Oral Ibuprofen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral APAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Ibuprofen and Oral APAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sergey Motov, MD

Maimonides Medical Center

Phone: 7182836000

Email: smotov@maimonidesmed.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place