Nebulized vs. Oral Midazolam Sedation in Pediatric Anesthesia: A Randomized Comparative Study

Cairo University (CU)

Status: Completed

Conditions: Preoperative Sedation

Treatments: Drug: Midazolam oral solution; Drug: Midazolam nebulized

Study type: Interventional

Funder types: Other

Identifiers

NCT04760041

SMS2021-1

Details and patient eligibility

About

This study is to be carried out to compare nebulized and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatrics.

Full description

This study is to be carried out to compare nebulized midazolam and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatric surgical patients.

In Pediatric Specialized Hospital, Cairo University 72 pediatric patients scheduled for undergoing general or uro-surgical operations under general anesthesia will be included in this double-blinded study. Patients will be randomly assigned into two equal groups, each group including 36 patients. In one group 36 children will receive nebulized midazolam 0.2 mg/kg in 3 ml normal saline plus 5 ml clear juice (orally) 30 min before undergoing general anesthesia. In the other group 36 children will receive oral midazolam 0.5 mg/kg in 5 ml clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing GA.

level of sedation will be compared between both groups

Enrollment: 72 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients from 2 to 6 years undergoing uro-surgery and general surgical procedures.
• Duration of surgery 1-2 hours
• Gender eligible for the study: both.
• ASA I-II.

Exclusion criteria

• ASA III-IV
• Patients with elevated levels of serum ALT, Creatinine.
• Emergency surgeries.
• Pre-existing neurologic disease.
• Parent refusal.
• History of allergy to midazolam.
• Patients with atopy or a history of asthma.
• Lengthy procedures of more than 2 hours

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups

nebulized midazolam group

Active Comparator group

Description:

36 children will receive nebulized midazolam 0.2 mg/kg in 3 ml normal saline plus 5 ml clear juice 30 min before undergoing general anesthesia

Treatment:

Drug: Midazolam nebulized

oral midazolam group

Active Comparator group

Description:

36 children will receive oral midazolam 0.5 mg/kg in 5 ml clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing anesthesia

Treatment:

Drug: Midazolam oral solution