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

NCT04760041 | Completed

• 1 other identifier: SMS2021-1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Preoperative Sedation

Outcome Measures

Primary Outcomes (1)

• Time required to reach a satisfactory level of sedation

  time to reach ramsay sedation score 4

  from time of applying the nebulizer until 30 minutes

Secondary Outcomes (7)

• Acceptability of method of administration of midazolam by a grading system

  from time of giving midazolam oral or nebulized till 30 minutes

• Ease of separation from parents

  from 30 minutes after receiving midazolam till transfer to operating room

• acceptability of Face mask by grading systen

  from time of applying face mask till time of getting asleep at 1 minute intervals

• Recovery time

  time from discontinuation of anesthesia until regaining baseline sedation score at 5 minute intervals

• Changes in mean arterial blood pressure

  from start of sedation till 1 hour postoperative at 5 minute intervals

Study Arms (2)

nebulized midazolam group

ACTIVE COMPARATOR

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

Drug: Midazolam nebulized

oral midazolam group

ACTIVE COMPARATOR

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

Drug: Midazolam oral solution

Interventions

Midazolam nebulized DRUG

midazolam nebulized

Also known as: nebulizer

nebulized midazolam group

Midazolam oral solution DRUG

midazolam given oral

Also known as: oral

oral midazolam group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine Cairo university

Cairo, Egypt

Location

MeSH Terms

Interventions

Nebulizers and Vaporizers; Midazolam

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 18, 2021
• Study Start: March 1, 2021
• Primary Completion: July 15, 2021
• Study Completion: August 10, 2021
• Last Updated: April 11, 2022

Record last verified: 2022-04

Locations

EG (1)