Overview

Pre-operative Ketorolac Administration Has no Pre-emptive Analgesic Effect Following Total Abdominal Hysterectomy

Status:
Completed
Trial end date:
2001-11-01
Target enrollment:
0
Participant gender:
Female
Summary
Background: Experimental models using short duration noxious stimuli have led to the concept of pre-emptive analgesia. Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), has been shown to have a post-operative narcotic sparing effect when given pre-operatively and alternatively to not have this effect. This study was undertaken to determine whether a single intravenous dose of ketorolac would result in decreased post-operative pain and narcotic requirements. Methods: In a double-blind, randomized controlled trial, 48 women undergoing abdominal hysterectomy were studied. Patients in the ketorolac group received 30 mg of intravenous ketorolac 30 minutes before surgical incision, while the control group received normal saline. The post-operative analgesia was performed with a continuous infusion of tramadol at 12 mg/hour with the possibility of a 10 mg bolus every 10 minutes. Pain was assessed using the Visual Analog Scale (VAS), tramadol consumption and hemodynamic parameters at 0, 1, 2, 4, 8, 12, 16 and 24 hours post-operatively. We quantified times to rescue analgesic (morphine), adverse effects and patient satisfaction.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital Arquitecto Marcide
Treatments:
Analgesics
Ketorolac
Ketorolac Tromethamine
Criteria
Inclusion Criteria:

- normal height and weight

- ASA class I, II, III

- elective surgery

- surgery time between 30-150 min

- understanding of the Visual Analog Scale (VAS)

- no allergies or intolerance to NSAIDs or anesthetics

- no psychiatric illness.

Exclusion Criteria:

- renal deterioration

- history of peptic ulceration

- asthma

- coagulopathy

- cognitive impairment

- inability to use the Patient Controlled Analgesia (PCA) device

- history of chronic pain syndromes

- history of chronic use of analgesics, sedatives, opioids or steroids

- liver or hematologic disease

- a history of drug or alcohol abuse

- therapy with NSAIDs, anticoagulants, or lithium.