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Adult Oral Ibuprofen Study for ED Pain Patients

NCT03441269 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2020-06-04

Study results available
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Summary

Ibuprofen is one of the most widely used non-steroidal anti-inflammatory drug (NSAID) for management of mild -to moderate pain in the ED (acute musculo-skeletal pain, headache, dental pain). Ibuprofen as a representative of NSAID's as a class follows the analgesic ceiling concept that postulates that there is a dose of a drug beyond which any further dosage increase results in no additional analgesic effect. Despite this fact, Ibuprofen may commonly be used at doses above its analgesic ceiling, although this may not offer an incremental analgesic advantage and potentially adds risk of harm. The analgesic ceiling dose for ibuprofen is only 200-400mg/dose, and about 1200 mg/day. Thus, we hypothesize that administration of Ibuprofen in a dose of 400 mg in the ED is as effective in treating mild-to-moderate acute pain in patients presenting to the ED as 600 mg and 800 mg

Conditions

  • Pain, Acute

Interventions

DRUG

Oral Ibuprofen

Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg

Sponsors & Collaborators

  • Antonios Likourezos

    lead OTHER

Principal Investigators

  • Sergey Motov, MD · Maimonides Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-06-30
Completion
2019-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03441269 on ClinicalTrials.gov