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

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.

Timeline

Start

2026-02-02

Primary completion

2027-07-01

Completion

2028-01-30

Publications

• Background Zin CS, Nazar NI, Rahman NSA, Ahmad WR, Rani NS, Ng KS. Patterns of initial opioid prescription and its association with short-term and long-term use among opioid-naive patients in Malaysia: a retrospective cohort study. BMJ Open. 2019 Jul 2;9(7):e027203. doi: 10.1136/bmjopen-2018-027203.
• Background Sveticic G, Gentilini A, Eichenberger U, Luginbuhl M, Curatolo M. Combinations of morphine with ketamine for patient-controlled analgesia: a new optimization method. Anesthesiology. 2003 May;98(5):1195-205. doi: 10.1097/00000542-200305000-00023.
• Background Sveticic G, Eichenberger U, Curatolo M. Safety of mixture of morphine with ketamine for postoperative patient-controlled analgesia: an audit with 1026 patients. Acta Anaesthesiol Scand. 2005 Jul;49(6):870-5. doi: 10.1111/j.1399-6576.2005.00740.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, Moller AM. Adding ketamine to morphine for intravenous patient-controlled analgesia for acute postoperative pain: a qualitative review of randomized trials. Br J Anaesth. 2010 Apr;104(4):401-6. doi: 10.1093/bja/aeq041. Epub 2010 Mar 5.
• 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 Tornoe 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 Nov;67(10):1306-1321. doi: 10.1111/aas.14307. Epub 2023 Jul 19.
• 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 (Phila Pa 1976). 2018 Mar 1;43(5):E299-E307. doi: 10.1097/BRS.0000000000002318.
• Background Schmid RL, Sandler AN, Katz J. Use and efficacy of low-dose ketamine in the management of acute postoperative pain: a review of current techniques and outcomes. Pain. 1999 Aug;82(2):111-125. doi: 10.1016/S0304-3959(99)00044-5.
• Background Hasan MS, Abdul Razak N, Yip HW, Lee ZY, Chan CYW, Kwan MK, Chiu CK, Yunus SN, Ng CC. Association between intraoperative remifentanil use and postoperative hyperalgesia in adolescent idiopathic scoliosis surgery: a retrospective study. BMC Anesthesiol. 2023 May 24;23(1):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, Durieux ME. Ketamine for perioperative pain management. Anesthesiology. 2005 Jan;102(1):211-20. doi: 10.1097/00000542-200501000-00030. No abstract available.
• 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. J Pediatr Orthop B. 2025 Jul 1;34(4):383-389. doi: 10.1097/BPB.0000000000001253. Epub 2025 Apr 29.
• 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, Siddaiah H, Cornett EM, Belani K, Salinas OJ, Fox CJ. Multimodal analgesia as an essential part of enhanced recovery protocols in the ambulatory settings. J Anaesthesiol Clin Pharmacol. 2019 Apr;35(Suppl 1):S40-S45. doi: 10.4103/joacp.JOACP_51_18.
• 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). 2017 Jun 1;42(11):838-843. doi: 10.1097/BRS.0000000000001902.
• Background Chiu CK, Chong KI, Chan TS, Mohamad SM, Hasan MS, Chan CYW, Kwan MK. The anatomical locations of postoperative pain and their recovery trajectories following Posterior Spinal Fusion (PSF) surgery in Adolescent Idiopathic Scoliosis (AIS) patients. Med J Malaysia. 2020 Jan;75(1):12-17.
• Background Yrjala 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 (Basel). 2022 Nov 10;9(11):1729. doi: 10.3390/children9111729.
• Background Seki H, Ideno S, Ishihara T, Watanabe K, Matsumoto M, Morisaki H. Postoperative pain management in patients undergoing posterior spinal fusion for adolescent idiopathic scoliosis: a narrative review. Scoliosis Spinal Disord. 2018 Sep 12;13:17. doi: 10.1186/s13013-018-0165-z. eCollection 2018.
• Background Deepak AS, Ong JY, Choon D, Lee CK, Chiu CK, Chan C, Kwan MK. The Clinical Effectiveness of School Screening Programme for Idiopathic Scoliosis in Malaysia. Malays Orthop J. 2017 Mar;11(1):41-46. doi: 10.5704/MOJ.1703.018.
• Background Lee JY, Moon SH, Kim HJ, Park MS, Suh BK, Nam JH, Jung JK, Lee HM. The prevalence of idiopathic scoliosis in eleven year-old Korean adolescents: a 3 year epidemiological study. Yonsei Med J. 2014 May;55(3):773-8. doi: 10.3349/ymj.2014.55.3.773. Epub 2014 Apr 1.
• Background Lee WS, Tay CG, Lum SH. Textbook of Paediatrics and Child Health. Kuala Lumpur: Universiti Malaya Press; 2020. p. 547-8.

Drugs

Indications