A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac

Study Overview
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Brief Summary
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The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).

Detailed Description
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The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS). The secondary objectives of this study are: To compare amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups. To compare time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups. To compare time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups. To compare the incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups.

Official Title
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A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac

Conditions
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Chronic Pelvic Pain

Intervention / Treatment
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* Drug: IV Ibuprofen
* Drug: IV Ketorolac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a preoperative diagnosis which is inclusive of chronic pelvic pain scheduled for Laparoscopic Surgery Exclusion Criteria: Inadequate IV access. History of allergy or hypersensitivity to any component of IVIb,ketorolac, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors. Less than 18 years of age or Greater than 65 years of age. Use of analgesics, including NSAIDs, less than 12 hours prior to surgery. Patients with active, clinically significant anemia. History or evidence of asthma or heart failure. Pregnant. 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. Patients with a history of Chronic Pain Conditions or Syndromes excluding patients with Chronic Pelvic Pain. Patients with known OSA

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ibuprofen versus ketoralac<br>IV ibuprofen (800 mg intravenous ibuprofen administered intravenously over 10 minutes) will be administered as a single dose prior to surgery at the initiation of anesthesia. A corresponding volume of NS will be administered to the group randomized to ketorolac, at the same time to maintain the study blind. | Drug: IV Ibuprofen<br>* Patients will be randomized to receive 800 mg intravenous ibuprofen or 30 mg ketorolac; each of the two treatment groups will consist of 25 patients.<br>* Other names: IV Caldolor;Drug: IV Ketorolac<br>* Patients will be randomized to receive 800 mg intravenous ibuprofen or 30 mg ketorolac; each of the two treatment groups will consist of 25 patients.<br>* Other names: IV Toradol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS). |  | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups |  | 1 Year | 
| Time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups |  | One Year | 
| Time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups |  | One Year | 
| Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups |  | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketorolac, Caldolor, Chronic Pelvic Pain