Investigating the effect of ketamine administration in controlling agitation in patients with opioid withdrawal syndrome at Loghman Hakim Hospital: a clinical trial study

Evaluation of the effect of ketamine on the control of agitation caused by substance withdrawal syndrome using a randomized clinical trial design

A phase lll , randomized, double - blind, controlled clinical trial was conducted on 60 patients.

Eligible patients presenting to the study center will be recruited using convenience sampling. Participants will then randomly assigned to either ketamine or midazolam group using block randomization . Drug administration and assessment of agitation will be performed by separate personnel who are blinded to the treatment allocation , ensuring a double-blind study.

Patients aged 18 to 70 years presenting with moderate to severe agitation associated with substance withdrawal syndrome were included in the study .patients with history of hypersensitivity ketamine or benzodiazepines misuse ,or sever hepatic or renal impairment were excluded from the study

Intervention group:was administered intravenously at a dose of 0.6 mg/kg over a period of one hour Control group: Midazolam was administered as an initial dose of 0.1 mg/kg ,followed by a continuous infusion 0.1 mg/kg/h .

1. To provide robust clinical evidence supporting the use of ketamine as an effective therapeutic option for controlling agitation in patients experiencing substance withdrawal syndrome. 2. To improve the treatment protocols of the Emergency Department and Poisoning Unit at Loghman Hakim Hospital for the management of patients with severe agitation secondary to withdrawal syndrome. 3. To reduce the need for conventional sedatives, such as benzodiazepines, and minimize the adverse effects associated with their use. 4. To enhance patient safety through more rapid and effective control of agitation and by reducing high-risk behaviors associated with withdrawal syndrome.

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.

Drug administration and agitation assessment will be performed by separate individuals who are blinded to the treatment allocatin

Only anonymized and de-identified clinical and research data, including demographic and outcome data, may be shared for scientific purposes.

Six months after publication of the results

Researchers

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.

Loghman Hakim Hospital, Kamali Street, South Kargar Street, Chaharrah-e Lashgar, Tehran, Iran.

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.