Ketorolac-an Option for Post Operative Pain Management After Elective Cardiac Surgery. (NCT05361824) | Clinical Trial Compass
CompletedPhase 4
Ketorolac-an Option for Post Operative Pain Management After Elective Cardiac Surgery.
Pakistan60 participantsStarted 2021-01-01
Plain-language summary
OBJECTIVE: The purpose of this study was to compare the efficacy of Ketorolac versus Paracetamol as an adjunct to Nalbuphine in the management of post-operative pain following elective cardiac surgery.
STUDY DESIGN: Randomized (single-blind) control trial.
SAMPLING TECHNIQUE: Computer generated, randomized selection of patients with 50% probability of assignment into either group.
PLACE AND STUDY DURATION: (single center) SICU at the National Institute of Cardiovascular Diseases Hospital, Karachi over a period of six months, from January 1, 2021 up to June 30, 2021.
METHODS: Sixty patients (30 in each group) were randomly assigned to receive either Paracetamol (control) or Ketorolac (treatment), along with the usual Nalbuphine infusion, over the first 48 hours postoperatively. The control group received injection Paracetamol 1gm six hourly, whereas treatment group received injection Ketorolac 30mg eight hourly.
PRIMARY OUTCOME: The VAS (pain score) was evaluated at 6, 12, 18 and 24 hours post-extubation and a score of 4 or less was taken as a cut-off for adequate pain control.
SECONDARY OUTCOMES: The time taken to extubation postoperatively. The total dose of Nalbuphine administered to each patient and total chest tube drainage recorded over 48 hours postoperatively.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males and females between 18 years and above of age.
* Undergoing elective cardiac surgery.
* American Society of Anesthesiology (ASA) Physical Class 3 or 4.
Exclusion Criteria:
* • Patients pre-planned for delayed extubation (due to moderate to severe pulmonary artery hypertension, poor right ventricular function, rhythm disturbances or unstable vitals)
* Low cardiac output (cardiac index \< 2.0 l/min/m2, using transesophageal echocardiography, intraoperatively) after weaning off cardiopulmonary bypass or paitients already having pre-op ejection fraction \< 30%.
* Patients not comfortably ventilated or oxygenated, requiring high doses of sedation and neuromuscular blockage.
* Sensitivity or allergy to nonsteroidal anti-inflammatory drugs.
* History of peptic ulcer or gastrointestinal bleeding.
* Serum creatinine = 2.0 mg/dl or increase in serum creatinine of = 0.5 mg/dl or 25% within the preceding 10 days.
* Hepatic dysfunction.
* Bleeding disorder.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in pain severity
Timeframe: 6 hours apart for total 24 hours(6 hours, 12 hours , 18 hours and 24 hours) post extubation.
Trial details
NCT IDNCT05361824
SponsorNational Institute of Cardiovascular Diseases, Pakistan