Paracetamol Compared With Ketorolac for Post-operative Analgetic

NCT05523102 | Completed Phase 4

• 1 other identifier: 0254
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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)

Conditions

Pain, Postoperative

Keywords

Acetaminophen; Ketorolac; Postoperative pain; Pediatric; NSAID; Paracetamol; Opioid; Morphine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Opioid usage

  48 hours post operatively

• Adverse effects

  48 hours post operatively

Study Arms (2)

Paracetamol

EXPERIMENTAL

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

Drug: Paracetamol

Ketorolac

ACTIVE COMPARATOR

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

Drug: Ketorolac

Interventions

Paracetamol DRUG

Intravenous paracetamol/acetaminophen

Also known as: Acetaminophen

Paracetamol

Ketorolac DRUG

Intravenous ketorolac/NSAID

Also known as: NSAID

Ketorolac

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead
• Dr Cipto Mangunkusumo General Hospital: collaborator

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Ketorolac; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Rismala Dewi, Prof

  Fakultas Kedokteran Universitas Indonesia

  STUDY CHAIR

• Bernie E Medise, Dr

  Fakultas Kedokteran Universitas Indonesia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patient does not know what analgetics are given, investigator also do not evaluate pain therefore is masked from the intervention given
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrics Resident, Principal Investigator

Model Details: Computer generated, randomized selection of patients with 50% probability of assignment into either group Treatment group : paracetamol group Control Group: ketorolac

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: March 31, 2022
• Primary Completion: July 18, 2022
• Study Completion: August 2, 2022
• Last Updated: September 6, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)