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

NCT ID: NCT04760041

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-08-10

Brief Summary

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.

Detailed 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

Conditions

Preoperative Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

nebulized midazolam group

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

Group Type: ACTIVE_COMPARATOR

Midazolam nebulized

Intervention Type: DRUG

midazolam nebulized

oral midazolam 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 anesthesia

Group Type: ACTIVE_COMPARATOR

Midazolam oral solution

Intervention Type: DRUG

midazolam given oral

Interventions

Midazolam nebulized

midazolam nebulized

Intervention Type: DRUG

Midazolam oral solution

midazolam given oral

Intervention Type: DRUG

Other Intervention Names

nebulizer; oral

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sherif Mohamed Abd El Moneim Soaida, MD

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine Cairo university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

SMS2021-1

Identifier Type: -

Identifier Source: org_study_id