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Paracetamol Compared With Ketorolac for Post-operative Analgetic

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Paracetamol
Ketorolac
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Acetaminophen, Ketorolac, Postoperative pain, Pediatric, NSAID, Paracetamol, Opioid, Morphine

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Postoperative patients admitted to Neurosurgery HCU or PICU
  • Parents/guardian signed informed consent forms

Exclusion Criteria:

  • History of allergy to paracetamol and ketorolac
  • Administration of opioid 24 hours before surgery
  • Liver dysfunction
  • Renal failure

Sites / Locations

  • Cipto Mangunkusumo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paracetamol

Ketorolac

Arm Description

Paracetamol 15mg/kg 6 hourly for 48 hours post-operatively

Ketorolac 0.5mg/kg 8 hourly for 48 hours post-operatively

Outcomes

Primary Outcome Measures

Pain change
Post operative analgesic assessment using rFLACC: a pain scoring used primarily for unconscious or disabled children. 0 no pain at all, 10: worst pain (range 0 - 10) Grading is based on the clinical and subjective signs defined in the scoring. For the purposes of this study "adequate pain relief" was defined as achieving a pain score of four or less.

Secondary Outcome Measures

Change in Opioid usage
Change in opioid administration as an opioid analgesic
Adverse effects
Increase of ALT/AST 3 times above normal range, AKI risk stage, gastrointestinal bleeding

Full Information

First Posted
August 29, 2022
Last Updated
August 31, 2022
Sponsor
Indonesia University
Collaborators
Dr Cipto Mangunkusumo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05523102
Brief Title
Paracetamol Compared With Ketorolac for Post-operative Analgetic
Official Title
Evaluation of Paracetamol as Post-operative Analgetic Modality Compared With Ketorolac
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
July 18, 2022 (Actual)
Study Completion Date
August 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
Dr Cipto Mangunkusumo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Post-operative analgetic modalities vary between center to center, especially in Indonesia. Considerations include potency/effectivity of the analgetics to achieve adequate pain control as soon as possible, reducing the total opioid dose intake and overall reducing potential opioid adverse effects. NSAID have been known to have more adverse effects than acetaminophen (paracetamol) but offers a higher potency for analgetic effects. Here the investigators compare whether paracetamol is adequate as a post-operative analgetics and confers fewer overall adverse effects when compared with ketorolac (NSAID)
Detailed Description
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) PICU and Neurosurgery HCU at the Cipto Mangunkusumo National Referral Center Hospital, Jakarat, Indonesia, over a period of 6 months, from March to August 2022. METHODS: Eighty-five patients (46 in paracetamol group and 39 in ketorolac group) were randomly assigned to receive either Paracetamol (treatment) or Ketorolac (control), along with the usual pre and intraoperative sedative/analgetics, and opioid as indicated over the first 48 hours postoperatively. The treatment group received injection Paracetamol 15mg/kg six hourly, whereas control group received injection Ketorolac 0.5mg/kg eight hourly. PRIMARY OUTCOME: The rFLACC (pain score) was evaluated at 0, 8, 12, 24 and 48 hours post-operation and a score of 4 or less was taken as a cut-off for adequate pain control. SECONDARY OUTCOMES: The total dose of opioid administered to each patient and adverse effects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Acetaminophen, Ketorolac, Postoperative pain, Pediatric, NSAID, Paracetamol, Opioid, Morphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Computer generated, randomized selection of patients with 50% probability of assignment into either group Treatment group : paracetamol group Control Group: ketorolac
Masking
ParticipantInvestigator
Masking Description
Patient does not know what analgetics are given, investigator also do not evaluate pain therefore is masked from the intervention given
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paracetamol
Arm Type
Experimental
Arm Description
Paracetamol 15mg/kg 6 hourly for 48 hours post-operatively
Arm Title
Ketorolac
Arm Type
Active Comparator
Arm Description
Ketorolac 0.5mg/kg 8 hourly for 48 hours post-operatively
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Acetaminophen
Intervention Description
Intravenous paracetamol/acetaminophen
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
NSAID
Intervention Description
Intravenous ketorolac/NSAID
Primary Outcome Measure Information:
Title
Pain change
Description
Post operative analgesic assessment using rFLACC: a pain scoring used primarily for unconscious or disabled children. 0 no pain at all, 10: worst pain (range 0 - 10) Grading is based on the clinical and subjective signs defined in the scoring. For the purposes of this study "adequate pain relief" was defined as achieving a pain score of four or less.
Time Frame
Total 48 hours (0, 8, 12, 24 and 48 hours) post operation
Secondary Outcome Measure Information:
Title
Change in Opioid usage
Description
Change in opioid administration as an opioid analgesic
Time Frame
48 hours post operatively
Title
Adverse effects
Description
Increase of ALT/AST 3 times above normal range, AKI risk stage, gastrointestinal bleeding
Time Frame
48 hours post operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postoperative patients admitted to Neurosurgery HCU or PICU Parents/guardian signed informed consent forms Exclusion Criteria: History of allergy to paracetamol and ketorolac Administration of opioid 24 hours before surgery Liver dysfunction Renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rismala Dewi, Prof
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bernie E Medise, Dr
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Study Chair
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Paracetamol Compared With Ketorolac for Post-operative Analgetic

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