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Adult Oral Ibuprofen Study for ED Pain Patients

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ClinicalTrials.gov Identifier: NCT03441269
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

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

Condition or disease Intervention/treatment Phase
Pain, Acute Drug: Oral Ibuprofen Phase 4

Detailed Description:

STUDY DESIGN A randomized, double-blind trial to determine the analgesic equivalency of orally administered ibuprofen at 400 mg for the treatment of acute pain in comparison to with higher doses of 600 and 800 mg for managing mild-to-moderate pain of adult patients in the ED.

OUTCOME MEASURES The primary outcome will be reduction in numeric rating scale pain score at 60 minutes from medication administration. Secondary outcomes included rates and percentages of subjects experiencing adverse effects as well as percentage of patients requiring rescue analgesia

STUDY POPULATION Patients considered for inclusion will comprise adults aged 18 and older years who presented to the ED primarily for management of acute mild to moderate musculoskeletal pain, headache, or dental pain who would routinely be treated with oral iburpofen in our ED as determined by the treating attending or resident physician. Acute pain will be defined in our study as having an onset within 30 days or less. Exclusion criteria will include pregnancy or breastfeeding, active peptic ulcer disease, acute gastrointestinal hemorrhage, known history of severe renal or hepatic insufficiency, allergy to nonsteroidal anti-inflammatory drugs, and patients having already received analgesic medication. For the purposes of this study, ibuprofen will be used without co-administration of any other analgesics, with the exception of rescue medication.

STUDY LOCATION The study will be conducted at a 711-bed urban community teaching hospital with an annual ED census of greater than 120,000 visits.

DURATION OF ENROLLMENT Patients pain scores will be recorded at the beginning of the study and at 60 minutes post-administration of medication by utilizing NRS.

DESCRIPTION OF INTERVENTION AND ADMINISTRATION Once the patient is triaged, an initial pain score will be assessed. Patients will then have an initial evaluation by ED physician and, once deemed eligible for the study, the patient will be randomized to receive oral ibuprofen at a dose of 400mg, 600mg, or 800mg. The on-duty ED pharmacist will prepare 400 mg, 600 mg and 800 mg oral ibuprofen preparations in identical capsules according to predetermined randomization generated in SPSS by the research manager. Demographics, chief complaint and initial pain score will be recorded in the data sheet as well as prior analgesics use. Patients pain scores will be recorded at the beginning of the study and at 60 minutes post-administration by using NRS.

RANDOMIZATION/BLINDING The research manager and statistician independently of data collection will conduct the programming of the randomization list, confirmation of written consent acquisition, and statistical analyses. ED pharmacy investigators will maintain the randomization list, prepare the medication, and deliver it to the nurse caring for the study participant in a blinded manner. The preparing pharmacist, research manager, and statistician will be the only ones with knowledge of the study arm to which the participant would be randomized. Providers, participants, and the data-collecting research team will be blinded to the medication received. Study investigators will include treating physicians who will assisted in screening and supervising the research fellow, residents, and research coordinators, who will enroll patients and record pain scores and adverse effects at baseline and at 60 minutes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Oral Ibuprofen in Management of Mild to Moderate Pain in Adult Patients in the ED
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 400mg/dose
Oral Ibuprofen dose of 400mg/dose for mild to moderate acute pain in ED patients.
Drug: Oral Ibuprofen
Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg

Active Comparator: 600mg/dose
Oral Ibuprofen dose of 600mg/dose for mild to moderate acute pain in ED patients.
Drug: Oral Ibuprofen
Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg

Active Comparator: 800mg/dose
Oral Ibuprofen dose of 800mg/dose for mild to moderate acute pain in ED patients.
Drug: Oral Ibuprofen
Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg




Primary Outcome Measures :
  1. Pain Reduction at 60 minutes [ Time Frame: 60 minutes ]
    The difference in Numeric pain score (0-10 with 0 being no pain, 5 being moderate pain, and 10 being severe pain) from baseline to 60 minutes


Secondary Outcome Measures :
  1. Rates of Adverse Events [ Time Frame: 60 minutes ]
    Rates of Adverse Events for getting oral ibuprofen

  2. Rates of Requiring Rescue Analgesia [ Time Frame: 60 minutes ]
    Rates of Requiring Rescue Analgesia for pain management



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441269


Contacts
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Contact: Antonios Likourezos, MA, MPH 718-283-6896 alikourezos@maimonidesmed.org
Contact: Sergey Motov, MD 718-283-8693 smotov@maimonidesmed.org

Locations
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United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Antonios Likourezos, MPH       alikourezos@maimonidesmed.org   
Contact: Sergey Motov, MD       smotov@maimonidesmed.org   
Sponsors and Collaborators
Antonios Likourezos
Investigators
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Principal Investigator: Sergey Motov, MD Maimonides Medical Center

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Responsible Party: Antonios Likourezos, Research Manager, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT03441269     History of Changes
Other Study ID Numbers: 2017-08-04
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Antonios Likourezos, Maimonides Medical Center:
Emergency Medicine
Acute Pain
Oral Ibuprofen
Additional relevant MeSH terms:
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Ibuprofen
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action