Intranasal Dexmedetomidine Premedication in Children

NCT02250703 | Completed Phase 3 Results

• 1 other identifier: 2014-0131
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND INFORMATION AND RATIONALE Pediatric patients scheduled for dental procedures under general anesthesia can have significant anxiety before the procedure. They are commonly pre medicated to minimize distress and to facilitate a smooth induction of anesthesia. Oral Midazolam at 0.5mg/kg dose is more widely used for this purpose . However the commonly used maximum dose is up to 15mg. It also has many limitations such as paradoxical reaction, increased incidence of emergence delirium and negative postoperative behavior changes . Intranasal dexmedetomidine has been used an effective and safe alternative premedication to oral midazolam in children. At a dose of 2micrograms/kg, intranasal dexmedetomidine as premedication resulted in excellent sedation in children aged 5-8yrs with no adverse hemodynamic effects. It has other advantages such as providing analgesia and facilitating smooth emergence from anesthesia. The goal of this study is to find out if intranasal dexmedetomidine is a superior alternative as premedication to oral midazolam in children weighing more than 20kg undergoing general anesthesia for dental rehabilitation.

Conditions

Preoperative Sedation

Keywords

Premedication

Outcome Measures

Primary Outcomes (1)

• University of Michigan Sedation Scale

  Level of sedation at separation from parents and at the time of mask induction will be measured on a scale of 0 to 4 (University of Michigan Sedation Scale) University of Michigan Sedation Scale: 0 -Awake/Alert 1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation. 4 - Unarousable Moderately and Deeply sedated: Satisfactory Awake, minimally sedate, unarousable: Unsatisfactory

  Day 0:Just before the patient will be brought to the operating room

Secondary Outcomes (3)

• Acceptance of Mask Induction

  Day 0: At the time when anesthesia is induced

• Wake up Behavior

  Day 0: At the end of surgery when the patient recovers from anesthesia

• Presence of Amnesia to Mask Induction

  Day 0: at the time of discharge of the patient from the recovery room

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication

Drug: Midazolam

Dexmedetomidine

EXPERIMENTAL

In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).

Drug: Dexmedetomidine

Interventions

Midazolam DRUG

oral midazolam 0.5mg/kg upto maximum dose of 15mg

Midazolam

Dexmedetomidine DRUG

intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg

Dexmedetomidine

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children older than 5yrs and weighing more than 20kg , who are scheduled for ambulatory dental rehabilitation at Batson operating rooms.
• ASA classification 1 or 2

You may not qualify if:

• Known allergy to midazolam, dexmedetomidine,morphine, fentanyl, sevoflurane and propofol.
• uncorrected congenital heart disease or history of cardiac arrhythmia,
• children at risk for airway obstruction (OSA or cranio facial syndrome),
• pregnant minors

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

Children's of Mississippi/University of Mississipi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (10)

• Kain ZN, Mayes LC, Bell C, Weisman S, Hofstadter MB, Rimar S. Premedication in the United States: a status report. Anesth Analg. 1997 Feb;84(2):427-32. doi: 10.1097/00000539-199702000-00035.

  PMID: 9024042 BACKGROUND

• Lonnqvist PA, Habre W. Midazolam as premedication: is the emperor naked or just half-dressed? Paediatr Anaesth. 2005 Apr;15(4):263-5. doi: 10.1111/j.1460-9592.2005.01600.x. No abstract available.

  PMID: 15787915 BACKGROUND

• Kanegaye JT, Favela JL, Acosta M, Bank DE. High-dose rectal midazolam for pediatric procedures: a randomized trial of sedative efficacy and agitation. Pediatr Emerg Care. 2003 Oct;19(5):329-36. doi: 10.1097/01.pec.0000092578.40174.85.

  PMID: 14578832 BACKGROUND

• McGraw T, Kendrick A. Oral midazolam premedication and postoperative behaviour in children. Paediatr Anaesth. 1998;8(2):117-21. doi: 10.1046/j.1460-9592.1998.00724.x.

  PMID: 9549736 BACKGROUND

• Kain ZN, Caldwell-Andrews AA, Krivutza DM, Weinberg ME, Wang SM, Gaal D. Trends in the practice of parental presence during induction of anesthesia and the use of preoperative sedative premedication in the United States, 1995-2002: results of a follow-up national survey. Anesth Analg. 2004 May;98(5):1252-9, table of contents. doi: 10.1213/01.ane.0000111183.38618.d8.

  PMID: 15105196 RESULT

• Yuen VM, Hui TW, Irwin MG, Yuen MK. A comparison of intranasal dexmedetomidine and oral midazolam for premedication in pediatric anesthesia: a double-blinded randomized controlled trial. Anesth Analg. 2008 Jun;106(6):1715-21. doi: 10.1213/ane.0b013e31816c8929.

  PMID: 18499600 RESULT

• Akin A, Bayram A, Esmaoglu A, Tosun Z, Aksu R, Altuntas R, Boyaci A. Dexmedetomidine vs midazolam for premedication of pediatric patients undergoing anesthesia. Paediatr Anaesth. 2012 Sep;22(9):871-6. doi: 10.1111/j.1460-9592.2012.03802.x. Epub 2012 Jan 23.

  PMID: 22268591 RESULT

• Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.

  PMID: 24237879 RESULT

• Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. Epub 2012 Sep 5.

  PMID: 22950484 RESULT

• Sathyamoorthy M, Hamilton TB, Wilson G, Talluri R, Fawad L, Adamiak B, Wallace C, Borissova I, Heard C. Pre-medication before dental procedures: A randomized controlled study comparing intranasal dexmedetomidine with oral midazolam. Acta Anaesthesiol Scand. 2019 Oct;63(9):1162-1168. doi: 10.1111/aas.13425. Epub 2019 Jul 18.

  PMID: 31318038 DERIVED

MeSH Terms

Interventions

Midazolam; Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

All the consecutive patients were screened for eligibility. Patients were not selected on the basis of need for premedication.

Results Point of Contact

• Title: Madhankumar Sathyamoorthy. PI
• Organization: University of Mississippi Medical Center

msathyamoorthy@umc.edu

6018157066

Study Officials

• Madhankumar Sathyamoorthy, MBBS, MS

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 26, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 7, 2017
• Results First Posted: July 7, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)