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Dose Response Effects of Intravenous Ketamine Infusions for Refractory Chronic Non-Cancer Pain: A Randomized Controlled Trial

Dose Response Effects of Intravenous Ketamine Infusions for Refractory Chronic Non-Cancer Pain: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260324006
Enrollment
90
Registered
2026-03-24
Start date
2026-04-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient aged 18-80 years old with refractory chronic pain conditions, including spinal cord injury pain, phantom limb pain, complex regional pain syndrome, post-herpetic neuralgia, ischemic pain, refractory neuropathic pain, and refractory nociplastic pain. Ketamine infusion Dose response effects Refractory chronic non-cancer pain

Interventions

Dose 0.1 mg/kg/h Duration over 4 hours in an outpatient pain clinic, with 3 repeats (2-3 weeks apart) ,Dose 0.3 mg/kg/h Duration over 4 hours in an outpatient pain clinic, with 3 repeats (2-3 weeks ap
Experimental Drug,Experimental Drug,Experimental Drug
low-dose ketamine infusion,moderate dose ketamine infusion,High dose ketamine infusion

Sponsors

none
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 to 80 years 2. Diagnosed with refractory chronic pain, including but not limited to the following conditions: Spinal cord injury pain Phantom limb pain Complex regional pain syndrome (CRPS) Post-herpetic neuralgia Ischemic pain Refractory neuropathic pain Refractory nociplastic pain 3.Average pain intensity of 5 out of 10 or more on the Numerical Rating Scale (NRS) during the previous 7 days at the baseline assessment. 4.Failure to respond to standard treatment for at least 3 months, including one or more of the following: Pharmacologic treatment Physical therapy Interventional pain management procedures

Exclusion criteria

Exclusion criteria: 1.Presence of financial incentives or ongoing legal or compensation claims related to the pain condition. 2.Inability to complete study assessments or questionnaires. 3.Severe psychiatric comorbidities, including active suicidality or self-harm, psychosis, post-traumatic stress disorder (PTSD), or a history of substance use disorder or substance dependence (screened using PHQ-9 and GAD-7). 4.History of severe adverse reactions to ketamine. 5.Unstable cardiovascular conditions or contraindications to ketamine, such as increased intracranial or intraocular pressure, or severe hepatic or renal impairment. 6.Pregnancy, or any other medical condition that contraindicates ketamine administration. 7.Cancer-related pain

Design outcomes

Primary

MeasureTime frame
Pain score 3 months after the final ketamine infusion NRS

Secondary

MeasureTime frame
Effectiveness, safety 1-6 months after the final ketamine infusion NRS, PGIC, PSQI, BPI, GAD7, PHQ9, PCS, analgesic use, adverse effects

Countries

Thailand

Contacts

Public ContactSireedhorn Assavanop

King Chulalongkorn Memorial Hospital, Chulalongkorn University

sireedhorn.a@chulahospital.org6622564000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026