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

Jessa Hospital

Status: Completed

Conditions: Surgery; Anesthesia

Treatments: Drug: 30 mg IV ketorolac; Drug: 10 mg IV ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT05206110

f/2021/129

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Peri- and postoperative 10 mg Ketolorac

Experimental group

Description:

Patients undergoing LAVH, RARP or TLH will receive dosages of 10 mg ketolorac (IV).

Treatment:

Drug: 10 mg IV ketorolac

Peri- and postoperative standard-dose 30 mg Ketolorac

Active Comparator group

Description:

Patients undergoing LAVH, RARP or TLH will receive standard dosages of 30 mg ketolorac (IV).

Treatment:

Drug: 30 mg IV ketorolac