Ketorolac-an Option for Post Operative Pain Management After Elective Cardiac Surgery.

• Status: Completed
• Trial end date: 2021-07-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Cardiovascular Diseases, Karachi
• Treatments: Acetaminophen; Ketorolac

Criteria

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.