Health TrialsbyHealthPanel

Small Study Comparing Two Pain Medicines in Teenagers for Pain Control After Scoliosis Corrective Surgery.

ConditionAdolescent Idiopathic Scoliosis (AIS)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ketamine-Morphine PCA

    Combination product

    The patient in this group will receive PCA Morphine (1mg/mL) with addition of Ketamine (1mg/mL) in comparison with the other group.

  • Morphine (Intravenous patient-controlled analgesia)

    Drug

    This patient will receive PCA Morphine only (1mg/mL).

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Ketamine-Morphine PCA (1:1 ratio)Experimental treatment 1 intervention
Group B: Morphine only PCAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative Morphine Consumption

Total amount of intravenous morphine (in milligrams) administered via the Patient-Controlled Analgesia (PCA) device. This includes both the demand doses and any clinician-administered boluses.

Time frame
From end of surgery (Hour 0) to 48 hours post-operation (Day 2).

Secondary outcomes

1

Post-operative Pain Intensity

Patient-reported pain intensity measured using a Visual Analogue Scale (VAS). The scale ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

Time frame
At 6, 12, 18, 24, 30, 36, 42, and 48 hours post-operatively.
2

Incidence of Opioid-Related Adverse Events (ORAEs)

The number of participants experiencing one or more of the following opioid-related adverse events: nausea, vomiting, pruritus (itching), excessive sedation (defined by a Richmond Agitation-Sedation Scale (RASS) score of -1 and below), or respiratory depression (respiratory rate \< 8 breaths per minute).

Time frame
From the end of surgery through 48 hours post-operatively.
3

Duration of Hospital Stay

The total number of days from the date of surgery (Day 0) to the date of hospital discharge.

Time frame
From date of surgery until hospital discharge (approximately 3-7 days).
4

Time to First Post-operative Flatus

The time interval (in hours) from the end of surgery until the patient first reports the passage of gas (flatus). This serves as a proxy for the resolution of post-operative ileus.

Time frame
Up to 48 hours post-operatively.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Malaya

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: