Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery

NCT06979791 | Not Yet Recruiting Phase 2

• 1 other identifier: MD-394-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. The main questions it aims to answer are: Does combining intranasal dexmedetomidine with a reduced dose of midazolam achieve adequate sedation while minimizing adverse effects? How do different dosing regimens affect mask acceptance, parent separation, sedation levels, recovery times, and perioperative adverse events? Researchers will compare two groups: one receiving dexmedetomidine plus a higher dose of midazolam (0.4 mg/kg) and another receiving dexmedetomidine plus a lower dose of midazolam (0.2 mg/kg) to see if the reduced dose maintains sedation effectiveness while reducing side effects. Participants will: Receive intranasal dexmedetomidine (2 mcg/kg) combined with either 0.4 mg/kg or 0.2 mg/kg of intranasal midazolam. Undergo sedation scoring at 15 and 30 minutes after drug administration. Be assessed for ease of separation from parents and acceptance of anesthesia mask. Be monitored for vital signs, recovery times, and any perioperative adverse events.

Conditions

Preoperative Anxiety Experienced by the Pediatric Patient; Preoperative Anxiety

Keywords

"pediatric premedication" "dexmedetomidine" "midazolam" "sedation" "mask acceptance"

Outcome Measures

Primary Outcomes (1)

• Mask Acceptance Score (MAS) at time of induction

  Mask acceptance will be assessed at the time of anesthesia induction using the Mask Acceptance Score (MAS). A score of 1 or 2 will be considered satisfactory (excellent/good), while scores of 3 or 4 will be considered unsatisfactory. The percentage of children with satisfactory mask acceptance will be compared between groups.

  At the time of induction (approximately 30 minutes after premedication)

Secondary Outcomes (6)

• Sedation Level (MOASS) at 15 and 30 minutes after premedication

  15 minutes and 30 minutes after drug administration

• Child-Parent Separation Score

  Approximately 30 minutes after premedication (at time of separation)

• Heart Rate

  Baseline and immediately before anesthesia induction.

• Blood Pressure

  Baseline and immediately before anesthesia induction

• Time to Recovery (Modified Aldrete Score ≥ 9)

  From extubation until Modified Aldrete Score ≥9 is achieved, assessed up to 1 hour in the Post-Anesthesia Care Unit (PACU)

Study Arms (2)

Dexmedetomidine + Midazolam 0.4 mg/kg

EXPERIMENTAL

Drug: Dexmedetomidine + Midazolam 0.4 mg/kg

Dexmedetomidine + Midazolam 0.2 mg/kg

EXPERIMENTAL

Drug: Dexmedetomidine + Midazolam 0.2 mg/kg

Interventions

Dexmedetomidine + Midazolam 0.4 mg/kg DRUG

Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.4 mg/kg, administered 30 minutes before the induction of general anesthesia.

Dexmedetomidine + Midazolam 0.4 mg/kg

Dexmedetomidine + Midazolam 0.2 mg/kg DRUG

Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.2 mg/kg, administered 30 minutes before the induction of general anesthesia.

Dexmedetomidine + Midazolam 0.2 mg/kg

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients aged 1 to 8 years
• Scheduled for elective surgery under general anesthesia
• Surgery duration \< 1 hour
• ASA physical status I or II
• Parent or legal guardian able to provide informed consent

You may not qualify if:

• Refusal to participate by parent/guardian
• Nasal infections, pathology, or epistaxis
• Runny nose or upper respiratory tract infection
• Enlarged adenoids
• BMI \> 30
• Known allergy to dexmedetomidine or midazolam
• Fever on day of surgery
• Coagulopathy
• Scheduled for cardiothoracic or neurosurgical procedures
• Congenital heart disease
• Neurological or mental disorders
• Pre-existing sedation (MOASS \< 5) on the day of surgery

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Kasr Al-Ainy Hospital, Cairo University

Cairo, 11562, Egypt

Location

Souad Kafafi University Hospital, Misr University for Science and

Giza, Egypt

Location

Related Publications (6)

• Mountain BW, Smithson L, Cramolini M, Wyatt TH, Newman M. Dexmedetomidine as a pediatric anesthetic premedication to reduce anxiety and to deter emergence delirium. AANA J. 2011 Jun;79(3):219-24.

  PMID: 21751690 BACKGROUND

• Cohen LB, Delegge MH, Aisenberg J, Brill JV, Inadomi JM, Kochman ML, Piorkowski JD Jr; AGA Institute. AGA Institute review of endoscopic sedation. Gastroenterology. 2007 Aug;133(2):675-701. doi: 10.1053/j.gastro.2007.06.002. No abstract available.

  PMID: 17681185 BACKGROUND

• Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.

  PMID: 10702460 BACKGROUND

• Anttila M, Penttila J, Helminen A, Vuorilehto L, Scheinin H. Bioavailability of dexmedetomidine after extravascular doses in healthy subjects. Br J Clin Pharmacol. 2003 Dec;56(6):691-3. doi: 10.1046/j.1365-2125.2003.01944.x.

  PMID: 14616431 BACKGROUND

• Dhiman T, Verma V, Kumar Verma R, Rana S, Singh J, Badhan I. Dexmedetomidine-Ketamine or Dexmedetomidine-Midazolam Nebulised Drug Combination as a Premedicant in Children: A Randomised Clinical Trial. Turk J Anaesthesiol Reanim. 2022 Oct;50(5):380-387. doi: 10.5152/TJAR.2022.21298.

  PMID: 36301288 BACKGROUND

• Gomez-Manzano FJ, Laredo-Aguilera JA, Cobo-Cuenca AI, Rabanales-Sotos J, Rodriguez-Canamero S, Martin-Espinosa N, Carmona-Torres JM. Evaluation of Intranasal Midazolam for Pediatric Sedation during the Suturing of Traumatic Lacerations: A Systematic Review. Children (Basel). 2022 Apr 29;9(5):644. doi: 10.3390/children9050644.

  PMID: 35626821 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Ahmed AEH Ellhwany

CONTACT

+201013890313; ahmed.abdalaty2009@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Participants will be randomized to one of two treatment arms

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 20, 2025
• Study Start: June 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)