Adolescent Idiopathic Scoliosis (AIS)KetaMorphNCT07452705
Small Study Comparing Two Pain Medicines in Teenagers for Pain Control After Scoliosis Corrective Surgery.
A study testing Ketamine-Morphine PCA in people with Adolescent Idiopathic Scoliosis (AIS), run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- What is being tested?
- Ketamine-Morphine PCA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Feb 2026to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged > 10 years old
- Idiopathic scoliosis scheduled for single-stage posterior spinal fusion (PSF).
- American Society of Anaesthesiologists (ASA) physical status I-II.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
NIK SHERINA HAIDI BINTI HANAFI, MBBS, +6079492802, niksherina@um.edu.my
About this study
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
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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Being tested
- Ketamine-Morphine PCA, Morphine (Intravenous patient-controlled analgesia)
- Keywords
- Adolescent, Analgesia, Ketamine, Morphine, Pain management, Pain-controlled, Spinal fusion
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine-Morphine PCACombination product
Also called K-M
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
Also called M
This patient will receive PCA Morphine only (1mg/mL).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Morphine (Intravenous patient-controlled analgesia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From end of surgery (Hour 0) to 48 hours post-operation (Day 2).
Secondary outcomes (6)
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.
Measured: At 6, 12, 18, 24, 30, 36, 42, and 48 hours post-operatively.
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).
Measured: From the end of surgery through 48 hours post-operatively.
Duration of Hospital Stay
The total number of days from the date of surgery (Day 0) to the date of hospital discharge.
Measured: From date of surgery until hospital discharge (approximately 3-7 days).
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.
Measured: Up to 48 hours post-operatively.
Time to First Ambulation
The time interval (in hours) from the end of surgery until the patient first takes steps outside of their bed with or without assistance.
Measured: Up to 48 hours post-operatively.
Patient Satisfaction With Pain Management
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.
Measured: At the time of hospital discharge (approximately Day 3 to Day 7 post-operatively).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start2 Feb 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUHAMMAD FAEEZ BIN MOHD YUSOH, University of Malaya
- Investigators
- SITI NADZRAH BINTI YUNUS, MBBS, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452705
- Sponsor's protocol ID
- 2025817-15467
- Acronym
- KetaMorph
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and confidentiality considerations.
Publications
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.
PubMed 31270113Sveticic 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.
PubMed 12717142Sveticic 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.
PubMed 15954974Hodgman-Korth E, Kenyon NJ. Stability of morphine-ketamine admixtures for patient-controlled analgesia. J Pain Palliat Care Pharmacother. 2009;23:272-6.
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.
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.
PubMed 20207747Minoshima 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.
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.
PubMed 37468443Pendi 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.
PubMed 28700455Schmid 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.
PubMed 10467917Hasan 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.
PubMed 37226107Flood P, Rathmell JP, Shafer SL. Stoelting's Pharmacology and Physiology in Anesthetic Practice. 5th ed. New York: Wolters Kluwer; 2015.
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.
PubMed 15618805Hasan 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.
PubMed 40293731Fletcher 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07452705
- Acronym / sponsor ID
- KetaMorph / 2025817-15467
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Adolescent, Analgesia, Ketamine, Morphine, Pain management, Pain-controlled, Spinal fusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ketamine-Morphine PCA (1:1 ratio) | Experimental | Combination Product: Ketamine-Morphine PCAThis 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. |
| Morphine only PCA | Active comparator | Drug: Morphine (Intravenous patient-controlled analgesia)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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Aged > 10 years old
- Idiopathic scoliosis scheduled for single-stage posterior spinal fusion (PSF).
- American Society of Anaesthesiologists (ASA) physical status I-II.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine-Morphine PCAAlso: K-MThe patient in this group will receive PCA Morphine (1mg/mL) with addition of Ketamine (1mg/mL) in comparison with the other group. | Combination product | Ketamine-Morphine PCA (1:1 ratio) |
| Morphine (Intravenous patient-controlled analgesia)Also: MThis patient will receive PCA Morphine only (1mg/mL). | Drug | Morphine only PCA |
Primary outcome
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.
6 secondary outcomes
Post-operative Pain Intensity
Time frame: At 6, 12, 18, 24, 30, 36, 42, and 48 hours post-operatively.
Incidence of Opioid-Related Adverse Events (ORAEs)
Time frame: From the end of surgery through 48 hours post-operatively.
Duration of Hospital Stay
Time frame: From date of surgery until hospital discharge (approximately 3-7 days).
Time to First Post-operative Flatus
Time frame: Up to 48 hours post-operatively.
Time to First Ambulation
Time frame: Up to 48 hours post-operatively.
Patient Satisfaction With Pain Management
Time frame: At the time of hospital discharge (approximately Day 3 to Day 7 post-operatively).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Background: PubMed 31270113Zin 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: PubMed 12717142Sveticic 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: PubMed 15954974Sveticic 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.
- BackgroundHodgman-Korth E, Kenyon NJ. Stability of morphine-ketamine admixtures for patient-controlled analgesia. J Pain Palliat Care Pharmacother. 2009;23:272-6.
- BackgroundRoy 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: PubMed 20207747Carstensen 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.
- BackgroundMinoshima 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: PubMed 37468443Tornoe 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: PubMed 28700455Pendi 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: PubMed 10467917Schmid 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: PubMed 37226107Hasan 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.
- BackgroundFlood P, Rathmell JP, Shafer SL. Stoelting's Pharmacology and Physiology in Anesthetic Practice. 5th ed. New York: Wolters Kluwer; 2015.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and confidentiality considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SITI NADZRAH BINTI YUNUS, MBBS principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine-Morphine PCA in people with Adolescent Idiopathic Scoliosis (AIS), run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MUHAMMAD FAEEZ BIN MOHD YUSOH, MBBS (+6013-5233915, faeez@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Morphine Consumption (time frame: From end of surgery (Hour 0) to 48 hours post-operation (Day 2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07452705, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.