Paracetamol Compared With Ketorolac for Post-operative Analgetic

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05523102
• Other study ID #: 0254
• Status: Completed
• Phase: Phase 4
• Start date: March 31, 2022
• Est. completion date: August 2, 2022

Study information

• Verified date: August 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 2, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Paracetamol
Intravenous paracetamol/acetaminophen
• Ketorolac
Intravenous ketorolac/NSAID

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Dr Cipto Mangunkusumo General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Opioid usage	Change in opioid administration as an opioid analgesic	48 hours post operatively
Secondary	Adverse effects	Increase of ALT/AST 3 times above normal range, AKI risk stage, gastrointestinal bleeding	48 hours post operatively