Comparison efficacy of nebulized Dexmedetomidine-ketamine and midazolam-ketamine in preoperative sedation

Comparison efficacy of nebulized Dexmedetomidine-ketamine and midazolam-ketamine in preoperative sedation in pediatric

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20121205011676N7

Enrollment

Registered

2024-09-23

Start date

2024-08-05

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

efficacy of preoperative sedation for pediatric ophthalmic surgery.

Interventions

Intervention 1: The patients are divided into two groups: the intervention group includes patients with nebulized midazolam-ketamine. In the midazolam-ketamine nebulized group, it is 0.3 mg per kg of

Eligibility

Sex/Gender

All

Age

3 Years to 7 Years

Inclusion criteria

Inclusion criteria: ASA I and II Children aged 3-7 years3 Elective eye surgery under general anesthesia

Exclusion criteria

Exclusion criteria: Hepatic renal failure Neurologic disease Asthma

Design outcomes

Primary

Measure	Time frame
Sedation. Timepoint: Minutes fifteen and thirty. Method of measurement: The degree of sedation is evaluated using the RAMSAY sedation scale.1: Patient is anxious, agitated or restless, or both. 2: Patient is oriented, co-operative and tranquil. 3: Patient responds to commands only. 4: Patient exhibits brisk response to light glabellar tap or loud auditory stimulus. 5: Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus. 6: Patient exhibits no response.;Mask Acceptance. Timepoint: Minutes fifteen and thirty. Method of measurement: The acceptability of the face mask is determined based on the above Corda system: Excellent= Acceptance without any complaint; Good= Compliant, momentarily teary but then agreed to take medication; Fair= Complaint, initially disobedient but eventually agreed to take medication; Poor= Refuse medication.;Parental separation. Timepoint: Minutes fifteen and thirty. Method of measurement: At 0 and 15 minutes, separation anxiety is assessed using the Point Parental Separation Anxiety Scale (PSAS). 1. Easily detachable; 2. Moaning but confident; 3. She cries and can't be sure, clinging to her parents; 4. He cries and clings to his parents.;Determining the prevalence of nausea and vomiting after receiving medication. Timepoint: Minutes 0 and 15 and during postoperative recovery. Method of measurement: Minutes 0 and 15 minutes and during the recovery after the operation will be recorded by the doctor in the relevant form.	—

Measure

Time frame

Sedation. Timepoint: Minutes fifteen and thirty. Method of measurement: The degree of sedation is evaluated using the RAMSAY sedation scale.1: Patient is anxious, agitated or restless, or both. 2: Patient is oriented, co-operative and tranquil. 3: Patient responds to commands only. 4: Patient exhibits brisk response to light glabellar tap or loud auditory stimulus. 5: Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus. 6: Patient exhibits no response.;Mask Acceptance. Timepoint: Minutes fifteen and thirty. Method of measurement: The acceptability of the face mask is determined based on the above Corda system: Excellent= Acceptance without any complaint; Good= Compliant, momentarily teary but then agreed to take medication; Fair= Complaint, initially disobedient but eventually agreed to take medication; Poor= Refuse medication.;Parental separation. Timepoint: Minutes fifteen and thirty. Method of measurement: At 0 and 15 minutes, separation anxiety is assessed using the Point Parental Separation Anxiety Scale (PSAS). 1. Easily detachable; 2. Moaning but confident; 3. She cries and can't be sure, clinging to her parents; 4. He cries and clings to his parents.;Determining the prevalence of nausea and vomiting after receiving medication. Timepoint: Minutes 0 and 15 and during postoperative recovery. Method of measurement: Minutes 0 and 15 minutes and during the recovery after the operation will be recorded by the doctor in the relevant form.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbbas Ostadalipour

Tehran University of Medical Sciences

a-ostadalipour@tums.ac.ir+98 21 8856 3811

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026