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Completed

NCT Number: NCT05523102

Paracetamol Compared With Ketorolac for Post-operative Analgetic

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)

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Key information

Conditions

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

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

Drug

Intravenous paracetamol/acetaminophen

Other names: Acetaminophen

Ketorolac

Drug

Intravenous ketorolac/NSAID

Other names: NSAID

Primary outcomes

  1. Pain change

    Time frame: Total 48 hours (0, 8, 12, 24 and 48 hours) post operation

    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 outcomes

  1. Change in Opioid usage

    Time frame: 48 hours post operatively

    Change in opioid administration as an opioid analgesic

  2. Adverse effects

    Time frame: 48 hours post operatively

    Increase of ALT/AST 3 times above normal range, AKI risk stage, gastrointestinal bleeding

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Dr Cipto Mangunkusumo General Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 31, 2022
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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