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

NCT05361824 | Completed Phase 4 FDA Drug

• 1 other identifier: ERC-83/2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Post Operative Pain; Analgesia; Coronary Artery Bypass Grafting Surgery

Outcome Measures

Primary Outcomes (1)

• Reduction in pain severity

  Post operative analgesic assessment using Visual Analogue Scale VAS: a 10 cm long line between the two endpoints (0 to 10). 0: no pain at all 10: worst pain ever felt The mark that the patient pointed to, defined the patient's pain. For the purposes of this study "adequate pain relief" was defined as achieving a pain score of four or less, this designation was also included on the VAS scale and explained to the patients so that they may indicate numbers higher than four if they felt any pain.

  6 hours apart for total 24 hours(6 hours, 12 hours , 18 hours and 24 hours) post extubation.

Secondary Outcomes (3)

• Reduction in Opioid usage (if any)

  Within 48 hours postoperatively

• Time to Extubation in hours

  Within 24 hours postoperatively

• Total amount of blood (in milliliters) collected, in the under-water sealed drain bottles, via chest drainage tubes

  Within 48 hours postoperatively

Study Arms (2)

Ketorolac

EXPERIMENTAL

Ketorolac 30mg 8 hourly for 48 hours post-operatively

Drug: Ketorolac Injection

Paracetamol

ACTIVE COMPARATOR

Paracetamol 1gm 6 hourly for 48 hours post-operatively

Drug: Paracetamol

Interventions

Ketorolac Injection DRUG

dosage form: intravenous dosage: 30mg frequency: 8 hours apart (TDS) duration: for 48 hours post operatively

Also known as: Toradol

Ketorolac

Paracetamol DRUG

dosage form: intravenous dosage: 1gm frequency: 6 hours apart (QID) duration: for 48 hours post operatively

Also known as: Bofalgan, Provas

Paracetamol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between 18 years and above of age.
• Undergoing elective cardiac surgery.
• American Society of Anesthesiology (ASA) Physical Class 3 or 4.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Pakistan: lead

Study Sites (1)

National Institute of Cardiovascular Diseases

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Coronary Artery Disease; Pain, Postoperative; Agnosia

Interventions

Ketorolac; Ketorolac Tromethamine; Acetaminophen; Valsartan

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Dr Maaida Muzaffar, FCPS

  National Institute of Cardiovascular Diseases, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 100ml infusion bottles identical in every aspect, except a unique label on them which was only known to investigator.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar Anesthesia

Model Details: Computer generated, randomized selection of patients with 50% probability of assignment into either group Treatment group : Ketorolac group Control Group: Paracetamol

Study Record Dates

• First Submitted: April 30, 2022
• First Posted: May 5, 2022
• Study Start: January 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: July 6, 2021
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)