Clinical trial NCT05523102: Paracetamol Compared With Ketorolac for Post-operative Analgetic
Official title: Evaluation of Paracetamol as Post-operative Analgetic Modality Compared With Ketorolac
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Acetaminophen
Ketorolac
Postoperative pain
Pediatric
NSAID
Paracetamol
Opioid
Morphine
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Dr Cipto Mangunkusumo General Hospital
First posted: 2022-08-31
Enrollment: 85
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Computer generated, randomized selection of patients with 50% probability of assignment into either group Treatment group : paracetamol group Control Group: ketorolac
Primary purpose: TREATMENT

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)

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Pain change
timeFrame: Total 48 hours (0, 8, 12, 24 and 48 hours) post operation
Secondary outcomes:
measure: Change in Opioid usage
timeFrame: 48 hours post operatively
measure: Adverse effects
timeFrame: 48 hours post operatively
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Rismala Dewi, Prof
role: STUDY_CHAIR
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Bernie E Medise, Dr
role: STUDY_CHAIR
References: