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

Chronic Pelvic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01514175
• Other study ID #: KACW1
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: June 14, 2011
• Last updated: May 15, 2012
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: May 2012
• Source: Culpeper Surgery Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Pelvic Pain

Intervention

Drug:
• IV Ibuprofen
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.
• IV Ketorolac
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.

Locations

Country	Name	City	State
United States	Culpeper Surgery Center	Culpeper	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Culpeper Surgery Center	Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups		1 Year	No
Secondary	Time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups		One Year	No
Secondary	Time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups		One Year	No
Secondary	Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups		One Year	No