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Assessing the Efficacy of IV Ibuprofen for Treatment of Pain in Orthopedic Trauma Patients

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ClinicalTrials.gov Identifier: NCT02152163
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Delray Medical Center

Brief Summary:

STUDY OBJECTIVES:

  1. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in decreasing pain in orthopedic trauma patients with fractures of the extremities, face, pelvis and/or ribs compared to patients not receiving the medication.
  2. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in decreasing the use of opioid analgesics among orthopedic trauma patients with fractures of the extremities, face, pelvis, and/or ribs compared to compared to patients not receiving the medication.

Condition or disease Intervention/treatment Phase
Pain Drug: IV Ibuprofen Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Assessing the Efficacy of IV Ibuprofen for Treatment of Pain in Orthopedic Trauma Patients
Actual Study Start Date : October 2012
Actual Primary Completion Date : April 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: IV Ibuprofen 800 mg
IV Ibuprofen 800 mg
Drug: IV Ibuprofen
Other Name: IV Caldolor

Placebo Comparator: IV Saline
IV Saline
Drug: placebo



Primary Outcome Measures :
  1. Efficacy of IV Ibuprofen in orthropedic trauma patients [ Time Frame: Pain Scale End of Day 5 ]
    Pain will be measured using either a Visual Anolog Scale or a Numeric Rating Scales. A baseline pain score will be obtained prior to adminstration either placebo or IV ibuprofen. Pain assessements will be obtained from both groups 4hrs/2days and then twice daily for a total of 5days.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Trauma patient admitted to Trauma ICU or Trauma Step-Down Units.
  2. Fracture of ribs, face, extremities and/or pelvis
  3. Age between 18 and 75 years old
  4. Adequate IV access
  5. Able to self report and communicate pain severity

Exclusion Criteria:

  1. History of allergy or hypersensitivity to any component of IV Ibuprofen, aspirin (or aspirin related products) NSAIDs, or COX-2 inhibitors
  2. Any intracranial or spinal cord trauma
  3. History of clinically significant bleeding disorders including ITP, DIC or platelet dysfunction
  4. Recent history of intracranial surgery or stroke (within past 30 days)
  5. History of ulcers, gastritis or previous GI bleeding
  6. Renal Impairment (Creatinine > 3.0 mg/dL)
  7. Pregnant or breastfeeding
  8. Otherwise unsuitable in the opinion of the treating physician at time of randomization.

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): NCT02152163


Locations
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United States, Florida
Delray Medical Center
Delray Beach, Florida, United States, 33484
Sponsors and Collaborators
Delray Medical Center
Investigators
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Principal Investigator: Russell Weisz, MD Delray Medical Center

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Responsible Party: Delray Medical Center
ClinicalTrials.gov Identifier: NCT02152163     History of Changes
Other Study ID Numbers: WIRB Protocol #20121749
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Keywords provided by Delray Medical Center:
Assessing the efficacy of IV Ibuprofen for Treatment of Pain in Orthopedic Trauma Patients
Additional relevant MeSH terms:
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Ibuprofen
Wounds and Injuries
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