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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05361824
Recruitment Status : Completed
First Posted : May 5, 2022
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
Dr Maaida Muzaffar, National Institute of Cardiovascular Diseases, Karachi

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Post Operative Pain Analgesia Coronary Artery Bypass Grafting Surgery Drug: Ketorolac Injection Drug: Paracetamol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Computer generated, randomized selection of patients with 50% probability of assignment into either group Treatment group : Ketorolac group Control Group: Paracetamol
Masking: Single (Participant)
Masking Description: 100ml infusion bottles identical in every aspect, except a unique label on them which was only known to investigator.
Primary Purpose: Supportive Care
Official Title: Ketorolac Verses Paracetamol as an Adjunct to Nalbuphine in Post Operative Pain Management in Elective Cardiac Surgery
Actual Study Start Date : January 1, 2021
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : July 6, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

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 Name: 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:
  • Bofalgan
  • Provas




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Reduction in Opioid usage (if any) [ Time Frame: Within 48 hours postoperatively ]
    Reduction in Nalbuphine administration as an opioid analgesic

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05361824


Locations
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Pakistan
National Institute of Cardiovascular Diseases
Karachi, Sindh, Pakistan
Sponsors and Collaborators
National Institute of Cardiovascular Diseases, Karachi
Investigators
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Principal Investigator: Dr Maaida Muzaffar, FCPS National Institute of Cardiovascular Diseases, Karachi
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Responsible Party: Dr Maaida Muzaffar, Registrar Anesthesia, National Institute of Cardiovascular Diseases, Karachi
ClinicalTrials.gov Identifier: NCT05361824    
Other Study ID Numbers: ERC-83/2020
First Posted: May 5, 2022    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only patient's unique hospital ID will be provided if required

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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
Additional relevant MeSH terms:
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Coronary Artery Disease
Pain, Postoperative
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
Ketorolac
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action