Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 9:45 PM
Study NCT ID:
NCT07452705
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Small Study Comparing Two Pain Medicines in Teenagers for Pain Control After Scoliosis Corrective Surgery.
Sponsor:
University of Malaya
Organization:
Study Overview
Official Title:
Patient-Controlled Analgesia (PCA) With Ketamine-Morphine (PCA KetaMorph) vs PCA Morphine for Postoperative Analgesia in Idiopathic Scoliosis Surgery - A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KetaMorph
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: