Low dose versus normal dose ketolorac for postoperative pain

Low dose versus normal dose ketorolac for postoperative pain after prostatectomy and hysterectomy: a Double-blind Randomized Controlled Non-inferiority Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004562-35-BE

Enrollment

100

Registered

2021-10-28

Start date

2021-11-25

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatectomy Hysterectomy MedDRA version: 20.0 Level: PT Classification code 10061916 Term: Prostatectomy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10021151 Term: Hysterectomy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Ketolorac Product Name: Taradyl Product Code: BE156493 Pharmaceutical Form: Injection/infusion INN or Proposed INN: KETOROLAC TROMETAMOL CAS Number: 74103-07-4 Concentration unit: mg milli

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the present study is to assess if 10 mg intraoperative ketorolac is non-inferior to the standard 30 mg dose for the duration of efficacy in the treatment of acute postoperative pain . Therefore, a monocenter, prospective, double-blind, randomized controlled non-inferiority trial will be designed to investigate 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). ;Secondary Objective: Postoperative pain intensity at rest and movement, as measured by an 11-point NRS at other time points including at the Post Anesthesia Care Unit (PACU) discharge, 2, 4, 6, 12, 16 and 24 hours after surgery. - Mean total postoperative intravenous piritramide consumption at PACU Total amount of intravenous piritramide used in the first 24h postoperative. - 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) - Overall patient satisfaction with pain therapy, as assessed with an 11-point NRS scale (where 0 = not satisfied at all and 10 = extremely satisfied). - GSR and EQ-5D, 1week postoperatively assessed with telephone-call - Adverse effects of ketorolac use or suspected by the use of ketorolac ;Primary end point(s): The primary non-inferiority outcome measure is postoperative pain intensity at rest, as measured by an 11-point NRS (where 0 = no pain, and 10 = worst pain imaginable) at 8 hours after surgery (right before next dose of study medication).;Timepoint(s) of evaluation of this end point: 8 hours after surgery	—

Measure

Time frame

Main Objective: The aim of the present study is to assess if 10 mg intraoperative ketorolac is non-inferior to the standard 30 mg dose for the duration of efficacy in the treatment of acute postoperative pain . Therefore, a monocenter, prospective, double-blind, randomized controlled non-inferiority trial will be designed to investigate 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). ;Secondary Objective: Postoperative pain intensity at rest and movement, as measured by an 11-point NRS at other time points including at the Post Anesthesia Care Unit (PACU) discharge, 2, 4, 6, 12, 16 and 24 hours after surgery. - Mean total postoperative intravenous piritramide consumption at PACU Total amount of intravenous piritramide used in the first 24h postoperative. - 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) - Overall patient satisfaction with pain therapy, as assessed with an 11-point NRS scale (where 0 = not satisfied at all and 10 = extremely satisfied). - GSR and EQ-5D, 1week postoperatively assessed with telephone-call - Adverse effects of ketorolac use or suspected by the use of ketorolac ;Primary end point(s): The primary non-inferiority outcome measure is postoperative pain intensity at rest, as measured by an 11-point NRS (where 0 = no pain, and 10 = worst pain imaginable) at 8 hours after surgery (right before next dose of study medication).;Timepoint(s) of evaluation of this end point: 8 hours after surgery

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Secondary

Measure	Time frame
Secondary end point(s): Postoperative pain intensity at rest, as measured by an 11-point NRS at other time points including at the Post Anesthesia Care Unit (PACU) discharge, 2, 4, 6, 12, 16 and 24 hours after surgery. - Postoperative pain intensity at movement, as measured by an 11-point NRS at other time points including at the Post Anesthesia Care Unit (PACU) discharge, 2, 4, 6, 8, 12, 16 and 24 hours after surgery. - Mean total postoperative intravenous piritramide consumption at PACU (milligram) - 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. - 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) - Overall patient satisfaction with pain therapy, as assessed with an 11-point NRS scale (where 0 = not satisfied at all and 10 = extremely satisfied). - GSR and EQ-5D, 1week postoperatively assessed with telephone-call - Adverse effects of ketorolac use or suspected by the use of ketorolac; 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. ;Timepoint(s) of evaluation of this end point: 2,4,6,8,12 and 16 hours after surgery	—

Measure

Time frame

Secondary end point(s): Postoperative pain intensity at rest, as measured by an 11-point NRS at other time points including at the Post Anesthesia Care Unit (PACU) discharge, 2, 4, 6, 12, 16 and 24 hours after surgery. - Postoperative pain intensity at movement, as measured by an 11-point NRS at other time points including at the Post Anesthesia Care Unit (PACU) discharge, 2, 4, 6, 8, 12, 16 and 24 hours after surgery. - Mean total postoperative intravenous piritramide consumption at PACU (milligram) - 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. - 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) - Overall patient satisfaction with pain therapy, as assessed with an 11-point NRS scale (where 0 = not satisfied at all and 10 = extremely satisfied). - GSR and EQ-5D, 1week postoperatively assessed with telephone-call - Adverse effects of ketorolac use or suspected by the use of ketorolac; 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. ;Timepoint(s) of evaluation of this end point: 2,4,6,8,12 and 16 hours after surgery

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Countries

Belgium

Contacts

Public ContactIna Callebaut

Jessa ziekenhuis vzw

ina.callebaut@jessazh.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026