Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy

Nephrectomy Clinical Trial

Official title:

The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy: a Double Blinded Randomized Placebo Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765232
• Other study ID #: 08-000747 LDN
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2008
• Last updated: December 21, 2011
• Start date: October 2008
• Est. completion date: November 2010

Study information

• Verified date: December 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having laparoscopic surgery to donate a kidney.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients donating a kidney via laparoscopic donor nephrectomy

Exclusion Criteria:

• History of NSAID allergy

• Asthma

• History of long term opioid use

• Intraoperative blood loss greater than 300 mL

• Postoperative hemodynamic instability

• Active peptic ulcer disease

• Advanced renal impairment (Cr > 2.0 mg/dL)

• Bleeding diathesis

• Current use of probenecid

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopic Donor Nephrectomy
• Nephrectomy
• Pain, Postoperative

Intervention

Drug:
• Ketorolac
90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
• Placebo
1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.

Locations

Country	Name	City	State
United States	Mayo Clinic	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain 'Right Now'	Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.	24 hours after the end of surgery	No
Primary	Morphine Equivalents of Concomitant Pain Medication	The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient.	24 hours after the end of surgery	No

External Links

•   Mayo Clinic Clinical Trials