Small Study Comparing Two Pain Medicines in Teenagers for Pain Control After Scoliosis Corrective Surgery.
Starting soon · Not applicable
Conditions studied: Adolescent Idiopathic Scoliosis (AIS)
In brief
The goal of this clinical trial is to evaluate whether adding low-dose ketamine to PCA morphine reduces opioid requirements after posterior spinal fusion surgery in adolescent idiopathic scoliosis patients. Selected patients aged 10-18 years undergoing elective AIS surgery at University Malaya Medical Centre will be randomised to ketamine-morphine or morphine-only PCA. The primary outcome is cumulative morphine consumption at 48 hours, with secondary outcomes including pain scores, opioid-related adverse effects, time to ambulation, and patient satisfaction. This study aligns with national priorities for safe opioid stewardship and enhanced peri-operative care in Malaysia.
Key facts
- Study ID
- NCT07452705
- Run by
- University of Malaya
- People needed
- 114
- Starts
- 2026-02-02
- Expected to finish
- 2028-01-30
- Last updated by the study team
- 2026-03-05
Who can join
Age: 10 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged > 10 years old
- Idiopathic scoliosis scheduled for single-stage posterior spinal fusion (PSF).
- American Society of Anaesthesiologists (ASA) physical status I-II.
You may not qualify if…
- Known hypersensitivity to morphine, ketamine or formulation excipients.
- Hepatic dysfunction (ALT or AST > 2 × upper limit of normal).
- Renal impairment (eGFR ≤ 60 mL min-¹ 1·73 m-²).
- Uncontrolled asthma or severe restrictive lung disease.
- Cardiac disease or clinically significant arrhythmia.
- Epilepsy.
- Intellectual disability precluding PCA use.
- Chronic opioid therapy or pre-operative pain > 3 months.
- Concomitant monoamine-oxidase inhibitor or tricyclic antidepressant therapy.
- History of severe postoperative delirium.
Where it is running
- University Malaya Medical Centre — Kuala Lumpur, Kuala Lumpur, Malaysia
Full record on ClinicalTrials.gov
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