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NCT Number: NCT07072117

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

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.

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Key information

Conditions

Adenotonsillectomy

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine - Zagazig University

Zagazig, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Other names: Intranasal Dexmedetomidine

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

Other names: Intranasal Ketamine

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

Other names: Intranasal Midazolam

Primary outcomes

  1. Measurement of the vital signs mean blood pressure

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

    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.

  2. Measurement of the heat rate

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

    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.

  3. Measurement of respiratory

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

    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.

  4. Scoring the incidence and severity of post-extubation laryngospasm

    Time frame: First 30 minutes after extubation

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

  5. Assessment of the sedation level done by Ramsay sedation score

    Time frame: First 30 minutes post-extubation

    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.

  6. Assessment of the sedation level done by Ramsay sedation score

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

    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.

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

    Time frame: During intravenous cannulation before anesthesia induction

    (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

  8. Time to achieve discharge readiness from PACU

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

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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Acronym: INPERM

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

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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