Low Dose Versus Normal Dose Ketorolac for Postoperative Pain After Prostatectomy and Hysterectomy

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A monocenter, prospective, double-blind, randomized controlled non-inferiority trial will be designed to investigate if ketorolac 10 mg is as effective for pain relief as the standard dose of 30 mg in patients undergoing robot assisted radical prostatectomy (RARP) or hysterectomy by laparoscopic assisted vaginal hysterectomy (LAVH) or total laparoscopic hysterectomy (TLH). It is hypothesised that the postoperative pain score at rest at 8 hours after surgery when receiving ketolorac 10 mg is non-inferior to the pain score at rest when receiving ketolorac 30mg.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jessa Hospital
• Treatments: Ketorolac; Ketorolac Tromethamine

Criteria

Inclusion Criteria:

• Patients between 18 and 70 years

• Patients undergoing RARP, LAVH or TLH

• ASA 1-3

• Scheduled as inpatient surgery (at least 1 night)

• Body weight > 60 kg

Exclusion Criteria:

• Refusal of the patient

• Cognitive impairment or no understanding of the Dutch language

• Allergy for salicylates or NSAID

• Pregnancy

• Active or history of peptic ulcer disease

• History of gastro-intestinal hemorrhage or perforation

• History of gastric bypass

• History of renal disease with creatinine > 1 mg/dl

• Haematological disease

• Tromboctopenia < 150000 / µl

• Current anticoagulant use

• Current clopidogrel use

• History of substance abuse or use of medication with a suppressive effect on the central nervous system