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

Overview

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.

Interventions

• Drug Dexmedetomidine + Midazolam 0.4 mg/kg
  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.
• Drug Dexmedetomidine + Midazolam 0.2 mg/kg
  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.

Primary outcome measures

• Mask Acceptance Score (MAS) at time of induction [Time frame: At the time of induction (approximately 30 minutes after premedication)]

Secondary outcome measures (6)

• Sedation Level (MOASS) at 15 and 30 minutes after premedication [Time frame: 15 minutes and 30 minutes after drug administration]
• Child-Parent Separation Score [Time frame: Approximately 30 minutes after premedication (at time of separation)]
• Heart Rate [Time frame: Baseline and immediately before anesthesia induction.]
• Blood Pressure [Time frame: Baseline and immediately before anesthesia induction]
• Time to Recovery (Modified Aldrete Score ≥ 9) [Time frame: From extubation until Modified Aldrete Score ≥9 is achieved, assessed up to 1 hour in the Post-Anesthesia Care Unit (PACU)]
• Perioperative Adverse Events [Time frame: 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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Egypt · 2 centers

• Kasr Al-Ainy Hospital, Cairo University — Cairo
• Souad Kafafi University Hospital, Misr University for Science and — Giza

Publications

• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06979791 · MD-394-2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗