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

NCT ID: NCT07072117

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2023-10-31

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

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.

Conditions

Adenotonsillectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

control group

Patients will receive 1 mL of 0.9% saline intranasally 30 minutes before induction of anesthesia.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DRUG

Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy

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

Intervention Type: DRUG

Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy

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

Intervention Type: DRUG

Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy

Dexmedetomidine Group

Patients will receive 2.0 μg/kg of intranasal dexmedetomidine, diluted in 0.9% saline to a total volume of 1 mL, 30 minutes before anesthesia induction.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy

Ketamine Group

Patients will receive 2 mg/kg of intranasal ketamine (50 mg/mL), diluted with 0.9% saline to a total volume of 1 mL, administered 30 minutes prior to anesthesia induction.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy

Midazolam Group

Patients will receive 0.1 mg/kg of intranasal midazolam, diluted in 0.9% saline to a final volume of 1 mL, administered 30 minutes before anesthesia induction.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy

Interventions

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

Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy

Intervention Type: DRUG

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

Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy

Intervention Type: DRUG

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

Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy

Intervention Type: DRUG

Other Intervention Names

Intranasal Dexmedetomidine; Intranasal Ketamine; Intranasal Midazolam

Eligibility 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Amira Saieed Elsayed Mousa

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amira Saeed Kenawy, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine - Zagazig University

Locations

Faculty of Medicine - Zagazig University

Zagazig, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

ZU-IRB#10231/11-1-2023

Identifier Type: OTHER

Identifier Source: secondary_id

zagu2025-INSI

Identifier Type: -

Identifier Source: org_study_id