Paracetamol Compared With Ketorolac for Post-operative Analgetic

NCT ID: NCT05523102

Last Updated: 2022-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2022-08-02

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

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Paracetamol

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

Group Type: EXPERIMENTAL

Paracetamol

Intervention Type: DRUG

Intravenous paracetamol/acetaminophen

Ketorolac

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

Group Type: ACTIVE_COMPARATOR

Ketorolac

Intervention Type: DRUG

Intravenous ketorolac/NSAID

Interventions

Paracetamol

Intravenous paracetamol/acetaminophen

Intervention Type: DRUG

Ketorolac

Intravenous ketorolac/NSAID

Intervention Type: DRUG

Other Intervention Names

Acetaminophen; NSAID

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role: collaborator

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Radhian Amandito

Pediatrics Resident, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rismala Dewi, Prof

Role: STUDY_CHAIR

Fakultas Kedokteran Universitas Indonesia

Bernie E Medise, Dr

Role: STUDY_CHAIR

Fakultas Kedokteran Universitas Indonesia

Locations

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

0254

Identifier Type: -

Identifier Source: org_study_id