Pain, Postoperative
Conditions
Keywords
Acetaminophen, Ketorolac, Postoperative pain, Pediatric, NSAID, Paracetamol, Opioid, Morphine
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
Interventions
DRUGParacetamol
Intravenous paracetamol/acetaminophen
DRUGKetorolac
Intravenous ketorolac/NSAID
Sponsors
Dr Cipto Mangunkusumo General Hospital
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Patient does not know what analgetics are given, investigator also do not evaluate pain therefore is masked from the intervention given
Intervention model description
Computer generated, randomized selection of patients with 50% probability of assignment into either group Treatment group : paracetamol group Control Group: ketorolac
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain change | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Opioid usage | 48 hours post operatively | Change in opioid administration as an opioid analgesic |
| Adverse effects | 48 hours post operatively | Increase of ALT/AST 3 times above normal range, AKI risk stage, gastrointestinal bleeding |
Countries
Indonesia
Outcome results
None listed