AzTrials
AzTrials

AnesthesiaNCT05206110

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

A study testing 10 mg IV ketorolac and 30 mg IV ketorolac in people with Anesthesia and Surgery, run by Jessa Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Anesthesia, Surgery
What is being tested?
10 mg IV ketorolac and 30 mg IV ketorolac
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteBelgium
Study dates
21 Apr 2022to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Jessa hospital

    Hasselt, Limburg, 3500

Other trials in Belgium

About this study

Official title: Low Dose Versus Normal Dose Ketorolac for Postoperative Pain After Prostatectomy and Hysterectomy: a Double-blind Randomized Controlled Non-inferiority Trial

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.

Read the detailed description

Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), is a commonly used and effective drug for moderate to severe postoperative pain. It is widely prescribed as one of the first steps in acute and postoperative pain since decades. Because of its non-opioid character, this type of drug is safe concerning the risk of addiction and respiratory depression in the postoperative setting, but other side-effects are well known.

Gastro-intestinal (GI) haemorrhage is the most feared complication. The risk of a GI-bleeding increases with age, higher doses and longer duration of therapy. Decrease in renal function seems less important than always assumed. Feldman et al proved that developing renal failure with the use of NSAIDs was rather rare (1,1%) and similar for ketorolac as for opioids. Nonetheless, the risk again increased in a linear fashion with the duration of use. Especially for the postoperative and trauma patient, the fear of platelet inhibition and subsequent bleeding has dominated restriction of its use. Other adverse effects of ketorolac, i.e. cardiovascular toxicity, asthma, allergic reaction, etc., are usually less of a concern for the physician.

In an attempt to reduce these unwanted side effects but still have the benefit of its highly effective analgesic activity, patients should be given the lowest effective dose. Several studies have already demonstrated that ketorolac analgesic efficacy at 10 mg is similar to that at higher doses due to a ceiling effect. Unfortunately, none of the published trials investigated pain scores of the alternative dose beyond 6 hours. Based on the pharmacokinetics of ketorolac, it is possible that the lower dose will loose its analgesic effect after a shorter period. To investigate whether this alternative dose of ketorolac will preserve its analgesic efficacy up to eight hours postoperative, the primary goal of this study will be the pain score after 8 hours, right before the next dose of ketorolac.

Conditions
Anesthesia, Surgery
Being tested
10 mg IV ketorolac, 30 mg IV ketorolac
Keywords
Ketolorac, Dosage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 10 mg IV ketorolacDrug

    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

  • 30 mg IV ketorolacDrug

    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

Study groups in NCT05206110
Study groupRoleWhat they receive
Peri- and postoperative 10 mg KetoloracExperimentalPatients undergoing LAVH, RARP or TLH will receive dosages of 10 mg ketolorac (IV).
Receives: Drug: 10 mg IV ketorolac
Peri- and postoperative standard-dose 30 mg KetoloracActive comparatorPatients undergoing LAVH, RARP or TLH will receive standard dosages of 30 mg ketolorac (IV).
Receives: Drug: 30 mg IV ketorolac

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain at rest 8 hours after surgery: Numeric Rating Scale (NRS)

    Pain at rest 8 hours after surgery (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)

    Measured: At 8 hours after surgery

Secondary outcomes (12)

  1. Pain at rest at PACU, 2, 4, 6, 12, 16 and 24 hours after surgery: Numeric Rating Scale (NRS)

    Pain at rest at PACU, 2, 4, 6, 12, 16 and 24 hours after surgery (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)

    Measured: At PACU, 2, 4, 6, 12, 16 and 24 hours after surgery

  2. Pain at movement at PACU, 2, 4, 6, 8, 12, 16 and 24 hours after surgery: Numeric Rating Scale

    Pain at movement at PACU, 2, 4, 6, 12, 16 and 24 hours after surgery (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)

    Measured: At PACU, 2, 4, 6, 8, 12, 16 and 24 hours after surgery

  3. Piritramide consumption at PACU (mg)

    Mean total postoperative intravenous piritramide consumption at PACU (milligram)

    Measured: At PACU until 2 hours after surgery

  4. Piritramide consumption first 24 hours postoperative (mg): PCIA pump

    Total amount of intravenous piritramide used in the first 24h postoperative. Use of piritramide will be objectified by a patient controlled intravenous analgesia (PCIA) pump. Information on piritramide consumption will be extracted from the PCIA-system and analyzed using 4-hour intervals.

    Measured: First 24 hours after surgery

  5. Quality of sleep during the first postoperative night: Numeric Rating Scale

    Quality of sleep during the first postoperative night, as measured by an 11-point NRS (where 0 = no sleep at all, and 10 = sleeping very well)

    Measured: First postoperative night

  6. Patient satisfaction: Numeric Rating Scale

    Overall patient satisfaction with pain therapy, as assessed with an 11-point NRS scale (where 0 = not satisfied at all and 10 = extremely satisfied).

    Measured: 1week postoperatively assessed with telephone-call

  7. Global Surgical Recovery Index

    General health status at that moment, as assessed with a scale (where 0=worst imaginable health status, and 100 = best imaginable health status)

    Measured: Before surgery (baseline) and 1 week postoperatively assessed with telephone-call

  8. EQ-5D

    Quality of life concerning mobility, self-care, pain/discomfort and anxiety/depression, as assessed with a score (where 0 = lowest quality of life, and 1 = highest quality of life)

    Measured: Before surgery (baseline) and 1 week postoperatively assessed with telephone-call

  9. Adverse effects of ketorolac use or suspected by the use of ketorolac

    Possible adverse effects related to ketolorac are: GI-bleeding, acute kidney failure (defined as an increase in serum creatinine by 1,5), postoperative bleeding (defined as the necessity of packed cells transfusion or surgical relook), allergic reaction and asthma exacerbation.

    Measured: During study completion, i.e. 1 week after the surgery

  10. Fear of the surgical procedure: Surgical fear questionnaire

    Fear of the surgical procedure using an 8-item Surgical Fear Questionnaire.

    Measured: Before surgery (baseline)

  11. Expected pain after surgery: Numeric Rating Scale

    Expected pain after surgery measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)

    Measured: Before surgery (baseline)

  12. Pain before surgery: Numeric Rating Scale

    Pain before surgery measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)

    Measured: Before surgery (baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2022
  2. Study start21 Apr 2022
  3. Primary completion5 Sep 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05206110
Sponsor's protocol ID
f/2021/129
Status last verified
May 2025
First submitted
7 Jan 2022
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 10 mg IV ketorolac and 30 mg IV ketorolac in people with Anesthesia and Surgery, run by Jessa Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain at rest 8 hours after surgery: Numeric Rating Scale (NRS) (time frame: At 8 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05206110.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in