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

NCT05206110 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-14

No results posted yet for this study

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.

Conditions

  • Anesthesia
  • Surgery

Interventions

DRUG

10 mg IV ketorolac

Patients undergoing LAVH, RARP or TLH will receive half an hour before the end of surgery, 10 mg ketorolac (IV). Also, 10 mg IV ketorolac will be given 8h and 16h after the surgery

DRUG

30 mg IV ketorolac

Patients undergoing LAVH, RARP or TLH will receive half an hour before the end of surgery, 30 mg ketorolac (IV). Also, 30 mg ketorolac will be given 8h and 16h after the surgery

Sponsors & Collaborators

  • Jessa Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2024-09-05
Completion
2024-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05206110 on ClinicalTrials.gov