NCT03441269

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
9 months until next milestone

Results Posted

Study results publicly available

June 4, 2020

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

February 15, 2018

Results QC Date

May 11, 2020

Last Update Submit

June 2, 2020

Conditions

Pain, Acute

Keywords

Emergency MedicineAcute PainOral Ibuprofen

Outcome Measures

Primary Outcomes (1)

  • Pain Reduction at 60 Minutes From Baseline of the 3 Oral Ibuprofen Groups

    Difference in mean pain scores among all groups from at 60 minutes from baseline; negative difference infers decrease in pain score. A pain score of 10 indicates severe pain, 5 indicates moderate pain and 0 indicates no pain.

    60 minutes

Secondary Outcomes (2)

  • Rates of Adverse Event of the 3 Oral Ibuprofen Dosage Groups

    60 minutes

  • Rates of Requiring Rescue Analgesia

    60 minutes

Study Arms (3)

400mg/dose

ACTIVE COMPARATOR

Oral Ibuprofen dose of 400mg/dose for mild to moderate acute pain in ED patients.

Drug: Oral Ibuprofen

600mg/dose

ACTIVE COMPARATOR

Oral Ibuprofen dose of 600mg/dose for mild to moderate acute pain in ED patients.

Drug: Oral Ibuprofen

800mg/dose

ACTIVE COMPARATOR

Oral Ibuprofen dose of 800mg/dose for mild to moderate acute pain in ED patients.

Drug: Oral Ibuprofen

Interventions

Oral IbuprofenDRUG

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

400mg/dose600mg/dose800mg/dose

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult ED patients aged 18 and older
  • Chief complaint of mild to moderate musculoskeletal pain, headache, or dental pain intensity of less than 4 on a standard 0 to 10 numeric rating scale.
  • Acute pain (within 30 days of onset)
  • Patients who would routinely be treated with oral ibuprofen

You may not qualify if:

  • pregnancy or breastfeeding,
  • active peptic ulcer disease,
  • acute gastrointestinal hemorrhage,
  • known history of severe renal or hepatic insufficiency, allergy to nonsteroidal anti-inflammatory drugs,
  • patients having already received analgesic medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (1)

  • Motov S, Masoudi A, Drapkin J, Sotomayor C, Kim S, Butt M, Likourezos A, Fassassi C, Hossain R, Brady J, Rothberger N, Flom P, Marshall J. Comparison of Oral Ibuprofen at Three Single-Dose Regimens for Treating Acute Pain in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2019 Oct;74(4):530-537. doi: 10.1016/j.annemergmed.2019.05.037. Epub 2019 Aug 2.

    PMID: 31383385DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Sergey Motov, MD
Organization
Maimonides Medical Center
alikourezos@maimonidesmed.org
718-283-8693

Study Officials

  • Sergey Motov, MD

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Manager

Study Record Dates

First Submitted

February 15, 2018

First Posted

February 22, 2018

Study Start

November 1, 2018

Primary Completion

June 30, 2019

Study Completion

August 31, 2019

Last Updated

June 4, 2020

Results First Posted

June 4, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)