Small Study Comparing Two Pain Medicines in Teenagers for Pain Control After Scoliosis Corrective Surgery.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10+
SponsorUniversity of Malaya
About this trial
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.
Eligibility criteria
Qualifiers
Aged > 10 years old
Idiopathic scoliosis scheduled for single-stage posterior spinal fusion (PSF).
American Society of Anaesthesiologists (ASA) physical status I-II.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ketamine-Morphine PCA
- Morphine (Intravenous patient-controlled analgesia)
Treatment groups
114 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov