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Completed

NCT Number: NCT01901393

Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery

The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS)

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Key information

Conditions

Pain Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shrock Orthopedic Research, Fort Lauderdale, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for knee arthroscopy

Exclusion criteria

  • Inadequate IV access.
  • History of allergy or hypersensitivity to any component of ibuprofen, ketorolac, aspirin (or aspirin related products), non-steroidal anti-inflammatory drugs (NSAIDs), opioids or cyclooxygenase-2 (COX-2) inhibitors.
  • Less than 18 years of age.
  • Use of analgesics less than 8 hours prior to surgery.
  • Patients with active, clinically significant anemia.
  • History or evidence of asthma or heart failure.
  • Pregnant.
  • Recent history of chronic opioid use.
  • Concomitant use of probenecid.
  • Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions and to return for the required assessments.
  • Refusal to provide written authorization for use and disclosure of protected health information.

Treatment and study plan

IV ibuprofen

Drug

Other names: Caldolor

Ketorolac

Drug

Other names: Ketorolac Tromethamine

Primary outcomes

  1. Efficacy of Pain Relief (Pain Intensity at Rest)

    Time frame: First possible time post-surgery, an expected average of 6 hours

    Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).

  2. Efficacy of Pain Relief (Pain Intensity With Movement)

    Time frame: First possible time post-surgery, an expected average of 6 hours

    Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).

Secondary outcomes

  1. Rescue Medication Use in Post-operative Period

    Time frame: Post-operative period until discharge, an expected average of 6 hours

    Amount of rescue medication (in milligrams) will be measured

  2. Time to First Use of Rescue Med Will be Measured

    Time frame: Post-operative period until discharge, an expected average of 6 hours

    Time to first rescue medication (in hours) in the postoperative period through discharge.

  3. Patient Satisfaction

    Time frame: Post-operative period until discharge, an expected average of 6 hours

    Measured using 2 question, 4 point scale.

  4. Incidence of Serious Adverse Events

    Time frame: Post-operative period until discharge, an expected average of 6 hours

    Number of subjects experiencing treatment-emergent serious adverse events

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Prospective, Randomized, Double-blind Study to Determine the Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2013
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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