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

September 28, 2022 updated by: Dr Maaida Muzaffar, National Institute of Cardiovascular Diseases, Karachi

Ketorolac Verses Paracetamol as an Adjunct to Nalbuphine in Post Operative Pain Management in Elective Cardiac Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

DATA COLLECTION: Computer randomization was done for the numbers 1 to 60, having 50% probability of being in either of two groups: Ketorolac (treatment) or Paracetamol (control).

After randomizing each number into either group, which ever patient (consenting and meeting the inclusion criteria) came, was allotted these numbers consecutively, as they presented for elective cardiac surgery. Thus randomly allocating the presenting patients into either Ketorolac/treatment (30 patients) and Paracetamol/control (30 patients).

Each patient was explained about the VAS pain rating score twice; first at preoperative interview and second time after they recovered their alert state in the SICU post operatively( at time of extubation).

The patients were taught to finger-point their intensity of pain on a line between two endpoints: marked 0 to 10. Mark at '0' meant no pain at all and '10' worst pain ever felt. The number 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.

Standard anaesthesia was given in the operative room, total analgesia given intra-operatively was 0.4 mg/kg Nalbuphine (not exceeding 30mg).

After completion of the surgery all patients were shifted to SICU. Initially both groups received a bolus dose of 10mg Nalbuphine and then an infusion of Nalbuphine was started at 2.5mg/hr as maintenance, up to 24 hours post-operatively. In addition, (according to randomization) the patients in treatment group received Ketorolac 30mg 8 hourly for 48 hours post-operatively and the patients control group received Paracetamol 1gm 6 hourly for 48 hours post-operatively.

Postoperative analgesia assessment using VAS was performed at 6 hours, 12 hours, 18 hours and 24 hours postextubation.

Time taken to extubation, total dose of Nalbuphine administered to each patient and total chest tube drainage were also recorded over 24 hours postoperatively.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • National Institute of Cardiovascular Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ketorolac
Ketorolac 30mg 8 hourly for 48 hours post-operatively
Drug: Ketorolac Injection
dosage form: intravenous dosage: 30mg frequency: 8 hours apart (TDS) duration: for 48 hours post operatively
Other Names:
  • Toradol
ACTIVE_COMPARATOR: Paracetamol
Paracetamol 1gm 6 hourly for 48 hours post-operatively
Drug: Paracetamol
dosage form: intravenous dosage: 1gm frequency: 6 hours apart (QID) duration: for 48 hours post operatively
Other Names:
  • Provas
  • Bofalgan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in pain severity
Time Frame: 6 hours apart for total 24 hours(6 hours, 12 hours , 18 hours and 24 hours) post extubation.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Opioid usage (if any)
Time Frame: Within 48 hours postoperatively
Reduction in Nalbuphine administration as an opioid analgesic
Within 48 hours postoperatively
Time to Extubation in hours
Time Frame: Within 24 hours postoperatively
Time taken from patient's entry into the surgical ICU after elective cardiac surgery, till the time Endotracheal tube was removed.
Within 24 hours postoperatively
Total amount of blood (in milliliters) collected, in the under-water sealed drain bottles, via chest drainage tubes
Time Frame: Within 48 hours postoperatively
The total amount (in milliliters) of blood collected via chest drains into the under-water sealed drain bottles
Within 48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cardiovascular Diseases, Karachi

Investigators

  • Principal Investigator: Dr Maaida Muzaffar, FCPS, National Institute of Cardiovascular Diseases, Karachi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ACTUAL)

June 30, 2021

Study Completion (ACTUAL)

July 6, 2021

Study Registration Dates

First Submitted

April 30, 2022

First Submitted That Met QC Criteria

April 30, 2022

First Posted (ACTUAL)

May 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERC-83/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only patient's unique hospital ID will be provided if required

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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