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

NCT01514175 | Unknown Phase 4

• 1 other identifier: KACW1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Pelvic Pain

Keywords

Ketorolac; Caldolor; Chronic Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

ibuprofen versus ketoralac

EXPERIMENTAL

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; Drug: IV Ketorolac

Interventions

IV Ibuprofen DRUG

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.

Also known as: IV Caldolor

ibuprofen versus ketoralac

IV Ketorolac DRUG

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.

Also known as: IV Toradol

ibuprofen versus ketoralac

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a preoperative diagnosis which is inclusive of chronic pelvic pain scheduled for Laparoscopic Surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Culpeper Surgery Center: lead
• Cumberland Pharmaceuticals: collaborator

Study Sites (1)

Culpeper Surgery Center

Culpeper, Virginia, 22701, United States

Location

MeSH Terms

Interventions

Ibuprofen; Ketorolac; Ketorolac Tromethamine

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Khalid Athar, MD

  Culpeper Regional Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: January 23, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

US (1)