Intranasal Dexmedetomidine, Ketamine or Midazolam for Anxiety and Respiratory Complications in Children | NCT07072117 | Trialant

CompletedInterventionalNot ApplicableUpdated Jul 18, 2025

Intranasal Dexmedetomidine, Ketamine or Midazolam for Anxiety and Respiratory Complications in Children

Comparison Between Intranasal Dexmedetomidine, Ketamine or Midazolam for Reducing Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07072117
Lead Sponsor: Zagazig UniversityOTHER_GOV
Overall Status: Completed
Study Type: Interventional
Phase: Not Applicable
Enrollment: 148Actual
Last Update Posted: Jul 18, 2025Actual
Start Date: Feb 20, 2023Actual
Primary Completion Date: Aug 20, 2023Actual
Completion Date: Oct 31, 2023Actual

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Comparison Between Intranasal Dexmedetomidine, Ketamine or Midazolam for Reducing Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy
Brief Summary: This study is being done to find out which of three medications-dexmedetomidine, ketamine, or midazolam-is best at reducing anxiety and breathing problems in children having surgery to remove their tonsils and adenoids. These medicines will be given as nose drops before anesthesia. Anxiety before surgery can cause stress and lead to problems like trouble breathing during or after surgery. The study will include 148 children aged 4 to 8 years. Each child will get one of the three medicines or a placebo (saline). Researchers will observe the children for signs of anxiety before surgery and for breathing problems, such as laryngospasm, after they wake up. The goal is to find the safest and most effective medicine to help children feel calmer and breathe safely during surgery.
Detailed Description

Conditions

The medical conditions and diseases this study investigates.

Adenotonsillectomy

Interventions

The treatments and procedures being evaluated in this study.

Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety & Respiratory Complications
Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications
Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Inclusion criteria

Parent or first-degree relative acceptance

Children with age ranged from 4 to8

Body mass index is equal to or greater than 5th and not more than 85th percentiles

ASA classifications Ⅰand Ⅱ

Both sex

Exclusion Criteria:

History of difficult intubation or extubation, cardiac, respiratory, renal and muscle diseases beside passive smoking and allergy to the tested drugs

History of obstructive sleep apnea (OSA).

The presence of the upper respiratory tract infection

The need to reoperation after tonsillectomy due to hemorrhage of more than 100ml of blood during surgery

Surgery duration is longer than 1.5 hour.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

Faculty of Medicine - Zagazig University

Zagazig, Egypt

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Zagazig UniversityOTHER_GOV

Similar Studies

Other registered studies that closely resemble this one.

Preoperative anxiety and respiratory complications are common in children undergoing adenotonsillectomy. Anxiety may result in behavioral changes and is associated with more difficult inductions and poorer recovery. Respiratory complications such as laryngospasm and airway obstruction are particularly dangerous in children, and minimizing these risks is a key goal of pediatric anesthesia.

Premedication with sedative drugs may help reduce anxiety and promote a smoother induction of anesthesia. The intranasal route of drug delivery is non-invasive and well tolerated in children, offering high bioavailability and avoiding the stress of IV insertion before surgery. Three commonly used intranasal medications-dexmedetomidine, ketamine, and midazolam-each have different pharmacological profiles and potential benefits.Dexmedetomidine is a selective alpha-2 adrenergic agonist that provides sedation and anxiolysis without causing respiratory depression. Ketamine is a dissociative anesthetic that reduces pain sensitivity and maintains respiratory drive. Midazolam is a benzodiazepine that provides rapid sedation and amnesia.

This randomized controlled trial will include 148 children aged 4 to 8 years undergoing adenotonsillectomy. Children will be randomly assigned to one of four groups: intranasal dexmedetomidine, ketamine, midazolam, or saline (placebo). The study is double-blinded, and the medications will be administered 30 minutes before anesthesia induction.

The primary goal is to assess and compare the incidence and severity of post-extubation laryngospasm within 30 minutes of extubation. Secondary objectives include assessing sedation level, preoperative anxiety, distress during IV cannulation, vital signs, and discharge readiness using standardized scoring systems such as the Ramsay Sedation Score, Groningen Distress Scale, and the Modified Aldrete Score.

The results of this study aim to determine the most effective and safest intranasal sedative premedication for pediatric patients, with the goal of improving surgical experiences, reducing complications, and enhancing recovery.