Paracetamol Compared With Ketorolac for Post-operative Analgetic

Study Overview
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Brief Summary
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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
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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

Official Title
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Evaluation of Paracetamol as Post-operative Analgetic Modality Compared With Ketorolac

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Ketorolac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Computer generated, randomized selection of patients with 50% probability of assignment into either group Treatment group : paracetamol group Control Group: ketorolac
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paracetamol<br>Paracetamol 15mg/kg 6 hourly for 48 hours post-operatively | Drug: Paracetamol<br>* Intravenous paracetamol/acetaminophen<br>* Other names: Acetaminophen;|
| Active Comparator: Ketorolac<br>Ketorolac 0.5mg/kg 8 hourly for 48 hours post-operatively | Drug: Ketorolac<br>* Intravenous ketorolac/NSAID<br>* Other names: NSAID;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Total 48 hours (0, 8, 12, 24 and 48 hours) post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Opioid usage | Change in opioid administration as an opioid analgesic | 48 hours post operatively | 
| Adverse effects | Increase of ALT/AST 3 times above normal range, AKI risk stage, gastrointestinal bleeding | 48 hours post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSAID, Acetaminophen, Ketorolac, Postoperative pain, Pediatric, Paracetamol, Opioid, Morphine