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

Cairo University72 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Preoperative Sedation

Interventions

Midazolam nebulizedDRUG

midazolam nebulized

Midazolam oral solutionDRUG

midazolam given oral

Eligibility

Sex: ALLMin age: 2 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of medicine Cairo university

Cairo, Egypt

Outcomes

Primary Outcomes

Time required to reach a satisfactory level of sedation

time to reach ramsay sedation score 4

Time frame: from time of applying the nebulizer until 30 minutes

Secondary Outcomes

Acceptability of method of administration of midazolam by a grading system

Facemask acceptance will be graded as poor (terrified, crying, and combative),fair (moderate fear of mask not calmed with reassurance),good (slight fear of mask, easily reassured), or excellent (unafraid, cooperative, and accepts mask readily).

Time frame: from time of giving midazolam oral or nebulized till 30 minutes

Ease of separation from parents

using ease of separation and induction scoring system: 1. Excellent: patient unafraid, cooperative, or asleep 2. Good: slight fear and/or crying, quiet with reassurance 3. Fair: moderate fear and crying, not quiet with reassurance 4. Poor: crying, need for restraint

Time frame: from 30 minutes after receiving midazolam till transfer to operating room

acceptability of Face mask by grading systen

Facemask acceptance was graded as poor (terrified, crying, and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured), or excellent (unafraid, cooperative, and accepts mask readily)

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

Recovery time

time to recover

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

Changes in mean arterial blood pressure

Changes in mean arterial blood pressure measured in mmHg

Data from ClinicalTrials.gov

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