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Completed

NCT Number: NCT04760041

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

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.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine Cairo university

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midazolam nebulized

Drug

midazolam nebulized

Other names: nebulizer

Midazolam oral solution

Drug

midazolam given oral

Other names: oral

Primary outcomes

  1. Time required to reach a satisfactory level of sedation

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

    time to reach ramsay sedation score 4

Secondary outcomes

  1. Acceptability of method of administration of midazolam by a grading system

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

    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).

  2. Ease of separation from parents

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

    using ease of separation and induction scoring system:

    • Excellent: patient unafraid, cooperative, or asleep
    • Good: slight fear and/or crying, quiet with reassurance
    • Fair: moderate fear and crying, not quiet with reassurance
    • Poor: crying, need for restraint
  3. acceptability of Face mask by grading systen

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

    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)

  4. Recovery time

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

    time to recover

  5. Changes in mean arterial blood pressure

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

    Changes in mean arterial blood pressure measured in mmHg

  6. changes in oxygen saturation

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

    changes in oxygen saturation

  7. changes in heart rate

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

    changes in heart rate

    changes in heart rate (beats per minute)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Nebulized Midazolam vs. Oral Midazolam as a Sedative Premedication in Pediatric Anesthesia: A Randomized Comparative Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2021
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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