Paracetamol Compared With Ketorolac for Post-operative Analgetic

University of Indonesia (UI)

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Paracetamol; Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT05523102

0254

Details and patient eligibility

About

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)

Full 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

Enrollment: 85 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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85 participants in 2 patient groups

Paracetamol

Experimental group

Description:

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

Treatment:

Drug: Paracetamol

Ketorolac

Active Comparator group

Description:

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

Treatment:

Drug: Ketorolac