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

NCT07452705 | Not Yet Recruiting

• 1 other identifier: 2025817-15467
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Keywords

Adolescent; Analgesia; Ketamine; Morphine; Pain management; Pain-controlled; Spinal fusion

Outcome Measures

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.

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

Secondary Outcomes (6)

• Post-operative Pain Intensity

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

• Incidence of Opioid-Related Adverse Events (ORAEs)

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

• Duration of Hospital Stay

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

• Time to First Post-operative Flatus

  Up to 48 hours post-operatively.

• Time to First Ambulation

  Up to 48 hours post-operatively.

Study Arms (2)

Ketamine-Morphine PCA (1:1 ratio)

EXPERIMENTAL

This group receives a ketamine-morphine PCA solution (1 mg mL-¹ + 1 mg mL-¹). This device deliver a 1 mL bolus, enforce a five-minute lock-out and cap delivery at 20 mL per four hours, with no background infusion. The patient will use PCA for at least 48 hours duration.

Combination Product: Ketamine-Morphine PCA

Morphine only PCA

ACTIVE COMPARATOR

This group receives morphine alone PCA (1 mg mL-¹). This device deliver a 1 mL bolus, enforce a five-minute lock-out and cap delivery at 20 mL per four hours, with no background infusion. The patient will use PCA for at least 48 hours duration.

Drug: Morphine (Intravenous patient-controlled analgesia)

Interventions

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.

Also known as: K-M

Ketamine-Morphine PCA (1:1 ratio)

Morphine (Intravenous patient-controlled analgesia) DRUG

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

Also known as: M

Morphine only PCA

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (23)

• Zin CS, Nazar NI, Rahman NSA, et al. Patterns of initial opioid prescription and its association with short-term and long-term use among opioid-naïve patients in Malaysia: a retrospective cohort study. BMJ Open. 2019;9:e027203. doi:10.1136/bmjopen-2018-027203

  BACKGROUND

• Sveticic G, Gentilini A, Eichenberger U, Luginbühl M, Curatolo M. Combinations of morphine with ketamine for patient-controlled analgesia: a randomized, double-blind, cross-over study. Anesthesiology. 2003;98(5):1195-1205. doi:10.1097/00000542-200305000-00014

  BACKGROUND

• Sveticic G, Farid R, Lauretti GR, et al. A safety audit of patient-controlled analgesia with ketamine and morphine after major surgery. Acta Anaesthesiol Scand. 2005;49(6):870-875. doi:10.1111/j.1399-6576.2005.00736.x

  BACKGROUND

• Hodgman-Korth E, Kenyon NJ. Stability of morphine-ketamine admixtures for patient-controlled analgesia. J Pain Palliat Care Pharmacother. 2009;23:272-6.

  BACKGROUND

• Roy JJ, Fortier C, Drolet P, et al. Physical compatibility of ketamine and morphine mixtures in PCA reservoirs. Can J Hosp Pharm. 2000;53:16-21.

  BACKGROUND

• Carstensen M, Møller AM. Adding ketamine to morphine for intravenous patient-controlled analgesia for acute postoperative pain: a qualitative review of randomised trials. Br J Anaesth. 2010;104:401-6.

  BACKGROUND

• Minoshima T, Fukushima S, Yokoyama H, et al. Intra-operative ketamine infusion reduces morphine requirement after adolescent spinal fusion: a randomised trial. Paediatr Anaesth. 2017;27:1064-71.

  BACKGROUND

• Tornøe AS, Pind AH, Laursen CCW, Andersen C, Maagaard M, Mathiesen O. Ketamine for postoperative pain treatment in spinal surgery: systematic review with meta-analysis and trial sequential analysis. Acta Anaesthesiol Scand. 2023;67(10):1306-21. doi:10.1111/aas.14307

  BACKGROUND

• Pendi A, Field R, Farhan SD, Eichler M, Bederman SS. Perioperative ketamine for analgesia in spine surgery: a meta-analysis of randomized controlled trials. Spine. 2018;43(5):E299-E307.

  BACKGROUND

• Schmid RL, Sandler AN, Katz J. Use and efficacy of low-dose ketamine in the management of acute postoperative pain: a review. Pain. 1999;82:111-25.

  BACKGROUND

• Hasan MS, Abdul Razak N, Yip HW, Lee ZY, Chan CYW, Kwan MK, et al. Association between intraoperative remifentanil use and postoperative hyperalgesia in adolescent idiopathic scoliosis surgery: a retrospective study. BMC Anesthesiol. 2023;23:177. doi:10.1186/s12871-023-02127-8

  BACKGROUND

• Flood P, Rathmell JP, Shafer SL. Stoelting's Pharmacology and Physiology in Anesthetic Practice. 5th ed. New York: Wolters Kluwer; 2015.

  BACKGROUND

• Himmelseher S, Duriex ME. Ketamine for perioperative pain management. Anesthesiology. 2005;102:211-20.

  BACKGROUND

• Hasan MS, Selvanathan P, Lee ZY, Chiu CK, Chan CYW, Kwan MK, Yunus SN. Perioperative intravenous lidocaine as an analgesic adjunct in adolescent idiopathic scoliosis surgery. Spine (Phila Pa 1976). 2020;45(20):E1261-E1269. doi:10.1097/BRS.0000000000003611

  BACKGROUND

• Fletcher D, Stamer UM, Pogatzki-Zahn E, et al. Pain management after surgery: a consensus statement from the ESA. Eur J Anaesthesiol. 2015;32:88-98.

  BACKGROUND

• Kaye AD, Urman RD, Rappaport Y, et al. Multimodal analgesia as an essential part of enhanced recovery protocols in the ambulatory settings. J Anaesthesiol Clin Pharmacol. 2019;35(Suppl 1):S40-5.

  BACKGROUND

• Kwan MK, Chiu CK, Chan TS, Chong KI, Mohamad SM, Hasan MS, Chan CYW. Trajectory of postoperative wound pain within the first 2 weeks following posterior spinal fusion surgery in adolescent idiopathic scoliosis patients. Spine (Phila Pa 1976). 2019;44(18):E1075-E1082.

  BACKGROUND

• Chiu CK, Chong KI, Chan TS, et al. The anatomical locations of postoperative pain and their recovery trajectories following posterior spinal fusion surgery in adolescent idiopathic scoliosis patients. Med J Malaysia. 2020;75(1):12-7.

  BACKGROUND

• Yrjälä T, Helenius I, Rissanen T, Ahonen M, Taittonen M, Helenius L. The extension of surgery predicts acute postoperative pain, while persistent postoperative pain is related to the spinal pathology in adolescents undergoing posterior spinal fusion. Children. 2022;9(11):1729. https://doi.org/10.3390/children9111729

  BACKGROUND

• Seki H, Ideno S, Ishihara T, et al. Postoperative pain management in patients undergoing posterior spinal fusion for adolescent idiopathic scoliosis: a narrative review. Scoliosis. 2018;13:17.

  BACKGROUND

• Deepak AS, Ong JY, Choon D, Lee K, Chiu CK, Chan C, Kwan K. The clinical effectiveness of a school screening programme for idiopathic scoliosis in Malaysia. Malays Orthop J. 2017;11(3):41-6. https://doi.org/10.5704/MOJ.1703.018

  BACKGROUND

• Lee JY, Moon SH, Kim HJ, Park M, Suh BK, Nam J, Jung J, Lee HM. The prevalence of idiopathic scoliosis in eleven-year-old Korean adolescents: A 3-year epidemiological study. Yonsei Med J. 2014;55(3):773-8. https://doi.org/10.3349/ymj.2014.55.3.773

  BACKGROUND

• Lee WS, Tay CG, Lum SH. Textbook of Paediatrics and Child Health. Kuala Lumpur: Universiti Malaya Press; 2020. p. 547-8.

  BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Morphine; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Analgesia; Anesthesia and Analgesia

Study Officials

• SITI NADZRAH BINTI YUNUS, MBBS

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MUHAMMAD FAEEZ BIN MOHD YUSOH, MBBS

CONTACT

+6013-5233915; faeez@ummc.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Medical Officer

Model Details: Informed consent (and assent where appropriate) will be obtained pre- operatively. An independent statistician will generate a computerised sequence in blocks of four. Sequentially-numbered opaque sealed envelopes (SNOSE; n = 114) will assign patients 1:1 to: * Group A Ketamine-Morphine PCA (K-M) * Group B Morphine-only PCA (M) An Acute Pain Service (APS) nurse not otherwise involved in the study will prepare identically labelled 30 mL polypropylene syringes (patient name + study ID only). Investigators, ward staff, surgeons and patients will remain blinded. In recovery, Group A receives a ketamine-morphine PCA solution (1 mg mL-¹ + 1 mg mL-¹); Group B receives morphine alone (1 mg mL-¹). Both devices deliver a 1 mL bolus, enforce a five-minute lock-out and cap delivery at 20 mL per four hours, with no background infusion.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: March 5, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)