Recruiting

KetorolacStudy of Whether 15 mg Dose of Ketorolac IV is as Effective as a 30 mg Dose.

Sponsor:

University of Calgary

Code:

NCT01230463

Conditions

Pain

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Ketorolac Tromethamine

Study Details

Brief summary:

The primary aim of this study is to show the non-inferiority of 15 mg intraoperative dose of ketorolac as compared to the standard 30 mg ketorolac by looking at the VAS scores 4 hours after an adult spine surgery.

Conditions

Pain

Pain, Postoperative

Study ID

NCT01230463

Start date

Sep, 2010

Status verified date

Oct, 2010

Completion date

Sep, 2011

Anticipated

Primary completion date

Sep, 2011

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients booked for 1-2 level spine laminectomies and/or decompression
Adult 18 - 65 years
Weight of 50 - 110 kg

Exclusion Criteria:

Previous lumbar laminectomy
Current anticoagulant use with INR > 1.2
Narcotic use > 4 weeks
Known allergy or sensitivity to NSAID or morphine
Renal insufficiency with creatinine >100 umol/L
Known liver disease
History of gastrointestinal bleeding
Pregnancy, history of bronchial asthma
NSAID use 2 days before surgery.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 15 mg ketorolac IV

active comparator: 30 mg ketorolac IV

Interventions

Ketorolac Tromethamine

15 mg ketorolac IV as a bolus 30 minutes before closure of surgery.

Ketorolac Tromethamine

30 mg ketorolac IV as a bolus 30 minutes before closure of surgery.

Primary outcome measure

Visual Analog Score [ Time Frame: Four hours after surgery ]

Central Contacts and Locations

Central contacts

Cecilia Deguzman, MD

403-944-1991 Cecilia.DeGuzman@albertahealthservices.ca

Kevin Yee, MD

403-944-1991 kevin.yee@albertahealthservices.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

More Information

Sponsor

University of Calgary

Last update posted

Oct 29, 2010

Last verified

Oct, 2010

Keywords

Pain, Postoperative
Ketorolac
Anti-Inflammatory Agents, Non-Steroidal
Intraoperative Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2010-10-29.