Clinical trial NCT06979791: Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery
Official title: Comparison Between the Effects of Adding Intranasal Dexmedetomidine to Two Different Doses of Midazolam as a Premedication in Pediatrics Undergoing Elective Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Preoperative Anxiety Experienced by the Pediatric Patient
Preoperative Anxiety
Keywords: &#34;pediatric premedication&#34; &#34;dexmedetomidine&#34; &#34;midazolam&#34; &#34;sedation&#34; &#34;mask acceptance&#34;
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two treatment arms
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mask Acceptance Score (MAS) at time of induction
timeFrame: At the time of induction (approximately 30 minutes after premedication)
Secondary outcomes:
measure: Sedation Level (MOASS) at 15 and 30 minutes after premedication
timeFrame: 15 minutes and 30 minutes after drug administration
measure: Child-Parent Separation Score
timeFrame: Approximately 30 minutes after premedication (at time of separation)
measure: Heart Rate
timeFrame: Baseline and immediately before anesthesia induction.
measure: Blood Pressure
timeFrame: Baseline and immediately before anesthesia induction
measure: Time to Recovery (Modified Aldrete Score ≥ 9)
timeFrame: From extubation until Modified Aldrete Score ≥9 is achieved, assessed up to 1 hour in the Post-Anesthesia Care Unit (PACU)
measure: Perioperative Adverse Events
timeFrame: From the time of drug administration until 1 hour post-discharge from the Post-Anesthesia Care Unit (PACU), or until the occurrence of a recorded adverse event, whichever comes first.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al-Ainy Hospital, Cairo University
city: Giza
country: Egypt
facility: Souad Kafafi University Hospital, Misr University for Science and
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.