Comparison of the effect of midazolam in oral and nebulized form

Assessment and Comparison of the effectiveness of nebulized vs. oral midazolam as a sedative premedication in pediatric eye surgery patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230117057153N1

Enrollment

Registered

2023-02-01

Start date

2023-02-05

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

This study is conducted for sedation in children undergoing eye surgeries. The entry criteria of our children should not have any underlying disease and be between 3 and 7 years old..

Interventions

Intervention 1: Intervention group: The patients will receive the nebulized midazolam will be 0.5 mg/kg in 5 cc normal saline and will be nebulized through the face mask. Intervention 2: Patients wi

Eligibility

Sex/Gender

All

Age

3 Years to 7 Years

Inclusion criteria

Inclusion criteria: ASA I and II Children aged 3 to 7 years Eye surgery under general anesthesia

Exclusion criteria

Exclusion criteria: Patients with renal or hepatic dysfunction History of midazolam allergy History of asthma Pre-existing neurologic disease

Design outcomes

Primary

Measure	Time frame
Determining sedation level using RAMSAY score within 30 minutes after administration of nebulized vs oral midazolam in pediatric eye surgery patients. Timepoint: 30 minutes after drug administration. Method of measurement: RAMSAY sedation score (0-6).	—

Secondary

Measure	Time frame
Time taken to reach RSS 4 (RSS= Ramsay Sedation Score ). Timepoint: Within 30 minutes whenever it reaches RSS 4. Method of measurement: Time Unit.;Facemask acceptance during drug delivery. Timepoint: During the sedation procedure. Method of measurement: Four point Mask Acceptance Scale 1.Excellent: Unafraid, cooperative, and accepts mask easily. 2, Good: Slight fear of mask, easily reassurediii. 3. Fair: Moderate fear of mask, not calmed with reassuranceiv. 4. Poor: Terrified, crying and combative.;Ease of separation from parents. Timepoint: At the end of drug delivery (after 30 minute). Method of measurement: Parental Separation Anxiety Scale (PSAS) Excellent = Patient unafraid, cooperative, or asleep Good= Slightly afraid/crying, quiet with reassurance Fair= Moderately afraid and crying, not quiet with reassurance Poor= Crying, need for restraint.;Changes in oxygen saturation. Timepoint: Baseline (at 0 minute after nebulization), 15th miinute and at 30th minute. Method of measurement: Oxygen saturation by pulse oximetry.;Changes in heart rate. Timepoint: At 0 minute after nebulization, 15th minute and 30th minute. Method of measurement: Heart rate in beat/minute.;Changes in blood pressure. Timepoint: At 0 minute after nebulization, 15th minute and 30th minute. Method of measurement: Blood pressure in mmHg.	—

Measure

Time frame

Time taken to reach RSS 4 (RSS= Ramsay Sedation Score ). Timepoint: Within 30 minutes whenever it reaches RSS 4. Method of measurement: Time Unit.;Facemask acceptance during drug delivery. Timepoint: During the sedation procedure. Method of measurement: Four point Mask Acceptance Scale 1.Excellent: Unafraid, cooperative, and accepts mask easily. 2, Good: Slight fear of mask, easily reassurediii. 3. Fair: Moderate fear of mask, not calmed with reassuranceiv. 4. Poor: Terrified, crying and combative.;Ease of separation from parents. Timepoint: At the end of drug delivery (after 30 minute). Method of measurement: Parental Separation Anxiety Scale (PSAS) Excellent = Patient unafraid, cooperative, or asleep Good= Slightly afraid/crying, quiet with reassurance Fair= Moderately afraid and crying, not quiet with reassurance Poor= Crying, need for restraint.;Changes in oxygen saturation. Timepoint: Baseline (at 0 minute after nebulization), 15th miinute and at 30th minute. Method of measurement: Oxygen saturation by pulse oximetry.;Changes in heart rate. Timepoint: At 0 minute after nebulization, 15th minute and 30th minute. Method of measurement: Heart rate in beat/minute.;Changes in blood pressure. Timepoint: At 0 minute after nebulization, 15th minute and 30th minute. Method of measurement: Blood pressure in mmHg.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSumaiya Zahra

Tehran University of Medical Sciences

sumaiyazahra110@gmail.com+98 21 8800 2651

Outcome results

None listed

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