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Completed

NCT Number: NCT01334957

Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of postoperative pain.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UC San Diego Regional Center, La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for surgery with anticipated need for postoperative analgesia

Exclusion criteria

  • Patients with inadequate IV access
  • Patients <18 years of age
  • History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
  • Active hemorrhage or clinically significant bleeding
  • Pregnant or nursing
  • Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
  • 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
  • Refusal to provide written authorization for use and disclosure of protected health information

Treatment and study plan

Intravenous Ibuprofen

Drug

800 mg intravenous ibuprofen administered intravenously over 5-10 minutes

Other names: Caldolor

Primary outcomes

  1. To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.

    Time frame: 6 hours

    The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen

  2. To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.

    Time frame: 6 hours

    The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen

Secondary outcomes

  1. To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.

    Time frame: 6 hours

    The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen

  2. To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.

    Time frame: 6 hours

    The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen

  3. To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.

    Time frame: 6 hours

    Visual Analog Scale (VAS) assessments following surgery. 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 o and 100.

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study title

A Multi-Center, Open-Label, Surgical Surveillance Trial To Evaluate The Safety And Efficacy Of A Shortened Infusion Time of Intravenous Ibuprofen

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Apr 13, 2011
Registry last updated
Feb 28, 2024

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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