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IRCT20091116002717N4 IRCT 2026-09-05 Shahid Beheshti University of Medical Sciences Investigation the effect of ketamine on agitation in substance withdrawal syndrom Investigating the effect of ketamine administration in controlling agitation in patients with opioid withdrawal syndrome at Loghman Hakim Hospital: a clinical trial study 2026-08-23 anticipated 60 Recruiting https://irct.ir/trial/92686 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization-Eligible patients who provide informed consent will be allocated to the intervention group (ketamine) or the control group (midazolam) using block randomization with a 1:1 allocation ratio. To maintain a balanced number of participants in the two groups, blocks of four Will be used. Each block will contain two allocations to the ketamine group and two allocations to the midazolam group, with the order of allocation randomly determined. The random allocation sequence will be generated using a computer-generated randomization program, and eligible patients will be assigned sequentially to one of the two groups according to the predetermined allocation sequence. A total of 60 patients will be enrolled, with 30 participants expected to be allocated to each group, Blinding description: Drug administration and agitation assessment will be performed by separate individuals who are blinded to the treatment allocatin. 3 Agitation due to substance withdrawal. Intervention 1: Intervention group:patients receiving ketamine . In the intervention group, ketamine will be administered intravenously at a dose of 0.6 mg/ kg over a period of one hour. In the control group, midazolam will be administered intravenously at an initial dose of 0.1 mg/kg, followed by continuous intravenous infusion of midazolam at a rate of 0.1 mg/kg/hour. Drug administration and patient monitoring will be performed according to the study protocol and standard patient monitoring and care procedures. Intervention 2: Control group: patient receiving midazolam. Yes - There is a plan to make this available What will be shared: Only anonymized and de-identified clinical and research data, including demographic and outcome data, may be shared for scientific purposes. When: Six months after publication of the results To whom: Researchers Conditions: Descriptive and inferential analyses related to the study objectives, including comparison of RASS scores, need for rescue medication, and adverse events between the study groups, are permitted on anonymized and de-identified data. Where to obtain: Loghman Hakim Hospital, Kamali Street, South Kargar Street, Chaharrah-e Lashgar, Tehran, Iran. How to obtain: Upon receipt of a request through official correspondence with the hospital, the relevant documents will be provided to the requester as soon as possible, following verification of the requester's identity and eligibility. Comments:
public Mostafazade babak
Loghman Hakim Hospital, Kamali Street, South Kargar Street, Chaharrah-e Lashgar, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1336616351 +98 21 5541 9005 mstzbmd@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mostafazade babak
Loghman Hakim Hospital, Kamali Street, South Kargar Street, Chaharrah-e Lashgar, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1336616351 +98 21 5541 9005 mstzbmd@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All patients aged 18 to 70 years with substance withdrawal syndrome accompanied by moderate to severe agitation 18 years 70 years Both Patients with a history of ketamine or benzodiazepine abuse or hypersensitivity to ketamine or benzodiazepines The presence of trauma or a life-threatening medical condition Sever hepatic or renal impairment Concomitant use of medications that interact with ketamine or benzodiazepines Treatment - Drugs Treatment - Drugs Intervention group:patients receiving ketamine . In the intervention group, ketamine will be administered intravenously at a dose of 0.6 mg/ kg over a period of one hour. In the control group, midazolam will be administered intravenously at an initial dose of 0.1 mg/kg, followed by continuous intravenous infusion of midazolam at a rate of 0.1 mg/kg/hour. Drug administration and patient monitoring will be performed according to the study protocol and standard patient monitoring and care procedures. Control group: patient receiving midazolam Severity of withdrawal-related agitation. Timepoint: 0-15-30-60-120 min. Method of measurement: Using the Richmond Agitation-Sedation Scale(RASS). Rescue medication requirement. Timepoint: Within 30 minutes after ketamine administration. Method of measurement: Recorded as yes/no. Adverse effect of ketamine. Timepoint: Up to 2h after administration. Method of measurement: Recording symptoms such as nausea-vomiting-hallucination. Shahid Beheshti University of Medical Sciences Approved 2026-07-26 Research Ethics Committee, Deputy for Research and Technology, Shahid Beheshti University of Medical Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Yadegar-e Emam (Shahid Chamran) Expressway, Yemen Street, Daneshjoo Boulevard, Koodakyar Dead End, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)