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

NCT07072117 | Completed DMC

• 2 other identifiers: zagu2025-INSIZU-IRB#10231/11-1-2023
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenotonsillectomy

Keywords

Pediatric anesthesia; Intranasal premedication; Dexmedetomidine intranasal; Ketamine intranasal; Midazolam intranasal; Preoperative anxiety; Respiratory complications; Laryngospasm in children

Outcome Measures

Primary Outcomes (8)

• Measurement of the vital signs mean blood pressure

  Mean arterial pressure (MAP) measured at seven time points: baseline (before intranasal drug), 10 minutes after drug administration, at induction, 10 and 30 minutes intraoperatively, and 10 and 30 minutes postoperatively.

  From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total)

• Measurement of the heat rate

  Heart rate measured at seven time points: baseline, 10 minutes after drug administration, at induction, 10 and 30 minutes intraoperatively, and 10 and 30 minutes postoperatively.

  From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total)

• Measurement of respiratory

  Respiratory rate measured at seven time points: baseline, 10 minutes after drug administration, at induction, 10 and 30 minutes intraoperatively, and 10 and 30 minutes postoperatively.

  From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total)

• Scoring the incidence and severity of post-extubation laryngospasm

  Incidence and severity of laryngospasm scored using a standardized 4-point scale during the first 30 minutes after extubation.

  First 30 minutes after extubation

• Assessment of the sedation level done by Ramsay sedation score

  Assessment of the sedation level done by Ramsay sedation score will be recoded at different time intervals: preoperative baseline before administration of intranasal medication, then 10 min, just before induction and 10 min, 20 min postoperative. "Ramsay Sedation Score" is described in 1974 it divides the pts level of sedation into 6 Categories ranging from severe agitation to deep coma.

  First 30 minutes post-extubation

• Assessment of the sedation level done by Ramsay sedation score

  Sedation level assessed using Ramsay Sedation Score at five time points: preoperative baseline (before drug administration), 10 minutes after drug, immediately before induction, and at 10 and 20 minutes postoperatively. The Ramsay Sedation Score is a 6-point scale ranging from anxiety/agitation to deep unresponsiveness.

  From baseline to 20 minutes after surgery (approximately 1 hour total)

• Assessment of distress associated with potentially painful event using Groningen distress scale at time of canulation.

  (GDS) was developed to grade distress associated with a potentially painful event. It can be used to monitor a phobic patient's experience towards a triggering stimulus. The original scale was developed at the University of Groningen in The Netherland

  During intravenous cannulation before anesthesia induction

• Time to achieve discharge readiness from PACU

  Monitoring for presence of sedation, nausea/vomiting, or other complications. Readiness assessed using Modified Aldrete Score.

  From arrival at PACU until Modified Aldrete Score >9 is achieved, up to 2 hours postoperatively.

Study Arms (4)

control group

PLACEBO COMPARATOR

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

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

Dexmedetomidine Group

EXPERIMENTAL

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.

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

Ketamine Group

EXPERIMENTAL

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.

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

Midazolam Group

EXPERIMENTAL

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.

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

Interventions

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

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

Also known as: Intranasal Dexmedetomidine

Dexmedetomidine Group; control group

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

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

Also known as: Intranasal Ketamine

Ketamine Group; control group

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

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

Also known as: Intranasal Midazolam

Midazolam Group; control group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine - Zagazig University

Zagazig, Egypt

Location

Study Officials

• Amira Saeed Kenawy, MD

  Faculty of Medicine - Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The study is double-blinded. The patients and anesthesia assistant (the person evaluating the effect of the tested drug) will not be informed about tested drug. Only the anesthesiologist (the person prescribing the tested drug) will be aware.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: July 18, 2025
• Study Start: February 20, 2023
• Primary Completion: August 20, 2023
• Study Completion: October 31, 2023
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)