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NCT Number: NCT07452705

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

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.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location contact

NIK SHERINA HAIDI BINTI HANAFI, MBBS

CONTACT

[email protected]

+6079492802

About this study

Posterior spinal fusion (PSF) is the definitive surgical treatment for patients with scoliosis. However, the procedure involves extensive tissue dissection, resulting in significant postoperative pain. Although patient-controlled analgesia (PCA) with intravenous morphine remains the current standard, the large doses required are frequently associated with side effects such as nausea, vomiting, pruritus, and sedation [4-6]. These complications delay mobilisation, prolong hospital stay, increase healthcare costs, and may contribute to opioid tolerance, undermining effective pain control.

Enhanced Recovery After Surgery (ERAS) protocols strongly promote multimodal analgesia, which combines opioid and non-opioid agents to achieve synergistic pain relief while minimising opioid exposure. This strategy has been shown to reduce side effects, improve recovery, shorten hospital stay, and lower the risk of opioid-related tolerance, hyperalgesia, and potential long-term dependence. Despite these advantages, evidence for the use of ketamine-morphine PCA in scoliosis surgery remains limited, and subanaesthetic ketamine-though effective intraoperatively as an opioid-sparing agent-remains underutilised in postoperative PCA regimens. Our previous study demonstrated that co-administration of subanaesthetic ketamine (0.5 mg/kg) at induction reduced postoperative pain sensitivity and hyperalgesia typically associated with high-dose remifentanil infusion, a strong opioid analgesic [13]. This finding underscores the potential role of ketamine as an opioid-sparing adjunct.

Building on this, we propose a single-centre, double-blind, randomised controlled trial in 114 idiopathic scoliosis patients undergoing elective PSF at University Malaya Medical Centre. Participants will be randomised to receive PCA containing ketamine-morphine (1 mg/mL + 1 mg/mL) or morphine (1 mg/mL) alone, with identical syringes to ensure allocation concealment. The primary endpoint is cumulative morphine consumption at 48 hours, while secondary outcomes include pain scores, opioid-related side effects, time to ambulation, and patient satisfaction.

This study aims to provide the first Malaysian evidence on an opioid-sparing PCA regimen, addressing national ERAS priorities and contributing to global opioid stewardship.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged > 10 years old
  • Idiopathic scoliosis scheduled for single-stage posterior spinal fusion (PSF).
  • American Society of Anaesthesiologists (ASA) physical status I-II.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: K-M

Morphine (Intravenous patient-controlled analgesia)

Drug

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

Other names: M

Primary outcomes

  1. Cumulative Morphine Consumption

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

    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.

Secondary outcomes

  1. Post-operative Pain Intensity

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

    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.

  2. Incidence of Opioid-Related Adverse Events (ORAEs)

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

    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).

  3. Duration of Hospital Stay

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

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

  4. Time to First Post-operative Flatus

    Time frame: Up to 48 hours post-operatively.

    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.

  5. Time to First Ambulation

    Time frame: Up to 48 hours post-operatively.

    The time interval (in hours) from the end of surgery until the patient first takes steps outside of their bed with or without assistance.

  6. Patient Satisfaction With Pain Management

    Time frame: At the time of hospital discharge (approximately Day 3 to Day 7 post-operatively).

    Patient-reported satisfaction with their pain management experience using a 5-point Likert scale. The scale consists of:

    • = Very Dissatisfied
    • = Dissatisfied
    • = Neutral
    • = Satisfied
    • = Very Satisfied Total scores range from 1 to 5, where higher scores indicate greater satisfaction with the pain management protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

MUHAMMAD FAEEZ BIN MOHD YUSOH, MBBS

CONTACT

[email protected]

+6013-5233915

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

Patient-Controlled Analgesia (PCA) With Ketamine-Morphine (PCA KetaMorph) vs PCA Morphine for Postoperative Analgesia in Idiopathic Scoliosis Surgery - A Randomized Controlled Trial

Acronym: KetaMorph

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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