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Completed

NCT Number: NCT06122948

Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication on the Occurrence of Postoperative Respiratory Adverse Events

The aim of this study is to investigate the effect of addition of intranasal ketamine to midazolam compared to midazolam alone as a premedication on the occurrence of PRAEs

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Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cairo university hospitals, kasralainy

Cairo, 11559, Egypt

About this study

Perioperative respiratory adverse events (PRAEs) are the most common complication during pediatric anesthesia furthermore, most children presenting for AT have sleep-disordered breathing and obstructive sleep apnea syndrome (OSAS) caused by tonsillar hypertrophy which could aggravate the PRAEs specially with the use of the conventional sedatives as a premedication. A recent randomized controlled trial has shown that more than 50% of children premedicated with midazolam had experienced PRAEs . Midazolam and ketamine are commonly used as preoperative sedative drugs for pediatric populations. Ketamine is a safe and widely used sedative and analgesic in the pediatric emergency department (ED) with less profound effects on the upper airway and respiratory muscles. Intranasal ketamine administration is well tolerated and without serious adverse effects. The addition of ketamine to midazolam as a preoperative sedation to reduce the occurrence of PRAEs was not investigated before in children undergoing AT. The authors hypothesize that combination of ketamine to midazolam could offer optimum sedation condition while reducing the occurrence of PRAEs in children undergoing AT.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children both sexes male and female.
  • Age from 3 to 12 years old.
  • ASA grade I, II.
  • undergoing elective AT procedures.

Exclusion criteria

  • Congenital heart diseases (cyanotic and a cyanotic).
  • Congenital syndromes affecting airway anatomy such as Pierre-Robin syndrome and Down syndrome.
  • Severe lung diseases affecting either lung tissue such as pulmonary cystic fibrosis and idiopathic pulmonary fibrosis or affecting lung circulation such as pulmonary hypertension with marked limitation of Physical activity or inability to carry out any physical activity according to NHYA classification.
  • Recent upper respiratory tract infection (less than two weeks).
  • Neuromuscular diseases including cerebral palsy and epilepsy.

Treatment and study plan

The midazolam group

Drug

The midazolam group will receive intranasal midazolam (0.1 mg/kg)

The midazolam ketamine group

Drug

the midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg)

Primary outcomes

  1. The incidence of any perioperative respiratory adverse events (PRAEs)

    Time frame: 8 hours

    the incidence of any PRAEs (Perioperative respiratory adverse events (PRAEs) which are manifested as minor (oxygen desaturation (SaO2 less than 95% for 10 seconds) or coughing) and major as (bronchospasm, laryngospasm, airway obstruction, stridor or hypoxia (oxygen desaturation less than 90%)) among midazolam versus midazolam ketamine groups.

Secondary outcomes

  1. Postoperative pain score

    Time frame: 8 hours

    • Postoperative pain score using (Wong-Baker Pain Scale)
  2. Sedation success rate

    Time frame: 8 hours

    • Sedation success rate (score of 3 or 4 is considered successful sedation) using Funk score
  3. Postoperative emergence delirium

    Time frame: 8 hours

    • Postoperative emergence delirium, a total Postoperative emergence delirium PAED score≥ 10 will be considered indicative of the presence of ED using (PAED scale

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication in Children Undergoing Tonsillectomy and Adenoidectomy on the Occurrence of Postoperative Respiratory Adverse Events: a Double-blind, Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
Oct 15, 2024

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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