A Phase 4 interventional study of Paracetamol and Ketorolac in Pain, Postoperative, sponsored by Universitas Indonesia. Completed at 1 site in Indonesia. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2022-09-06.
Sponsored by Universitas Indonesia · Phase 4, Interventional, and Treatment
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)
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
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 85 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Universitas Indonesia is the lead sponsor of 27 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Paracetamol 15mg/kg 6 hourly for 48 hours post-operatively
Drug: Paracetamol
Ketorolac 0.5mg/kg 8 hourly for 48 hours post-operatively
Drug: Ketorolac
Intravenous paracetamol/acetaminophen
Also known as: Acetaminophen
Intravenous ketorolac/NSAID
Also known as: NSAID
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.
Time frame: Total 48 hours (0, 8, 12, 24 and 48 hours) post operation
Change in Opioid usage
Change in opioid administration as an opioid analgesic
Time frame: 48 hours post operatively
Adverse effects
Increase of ALT/AST 3 times above normal range, AKI risk stage, gastrointestinal bleeding
Time frame: 48 hours post operatively
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2022 to primary completion in Jul 2022, 3 months.
Of 492 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's 3 months is below that.
Counting every sponsor, half of 497 studies reached it within 15 months; a quarter within 8 and three quarters within 31.
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetaminophen
Universitas Indonesia