Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment

NCT03827408 | Completed Phase 2 DMC

• 1 other identifier: IORG0008839
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.

Conditions

Dental Anxiety

Keywords

Nebulized Dexmedetomidine; Nebulized Midazolam; Moderate sedation; Dental procedural sedation; Pediatric dentistry

Outcome Measures

Primary Outcomes (13)

• Facemask acceptance during drug delivery

  It will be evaluated according to Zanaty \& Metainy as: poor (terrified, crying and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured) or excellent (unafraid, cooperative and accepts mask readily)

  during the sedation procedure

• Effect of sedation on children's future behavior

  Each child's behavior will be reassessed in the follow-up sessions and compared to that at baseline (before dental treatment) using Frankl scale (ranges from 0-4)

  after one week in the follow-up session

• The 'ease of treatment completion' sing separate five-point scales.

  This will be measured using separate five-point scales according to Surendar et al: Score 5 indicates an excellent quiet and cooperative child while score 1 indicates Prohibitive active resistance and crying; treatment cannot be rendered.

  immediately after completion of the dental treatment procedures.

• Post-operative effects of the sedation

  This will be assessed according to Modified Vernon et al.

  immediately after completion of the dental treatment procedures.

• Analgo-sedative effect of each drug

  Onset of Sedation from drug administration until the onset of satisfactory sedation

  during the sedation procedure (time taken from drug administration till reaching satisfactory sedation)

• Analgo-sedative effect of each drug

  Sedation level using Modified Observer's Assessment of Alertness/Sedation Scale. The scale is composed of 4 categories (each has scores ranging from 1-5). The categories are responsiveness, speech, facial expression and eyes. The final score is the sum of scores: the totally awake score is 20/20 and the deeply sedated score is 9/20

  during the sedation procedure (after drug administration until reaching satisfactory sedation)

• Analgo-sedative effect of each drug

  The analgesic effect of the sedative drugs will be assessed using "Face, Legs, Activity, Cry, Consolability" scale (FLACC). The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

  during local anesthesia injection to start the operative procedure

• Analgo-sedative effect of each drug

  The duration of sedation: defined as the onset of satisfactory sedation until the time of meeting discharge criteria according to the American Academy of Pediatric Dentistry.

  during the sedation procedure (from its onset till meeting discharge criteria)

• Analgo-sedative effect of each drug.

  Assessment of the most common procedural side effects such as (hypoxia, respiratory depression, agitation, arrhythmia, bradycardia, hypotension or hypertension, shivering, nausea and vomiting) will be recorded.

  during the sedation procedure (from its onset till meeting discharge criteria)

• Amnesic effect of sedative agents.

  Anterograde amnesia: will be assessed according to a modification of Bulach et al.

  immediately after completion of the dental treatment procedures.

• Hemodynamic response of sedative agents.

  Vital sign: Blood pressure (in mmHg) will be monitored using a sphygmomanometer.

  during the sedation procedure (from its onset till meeting discharge criteria)

• Hemodynamic response of sedative agents.

  Vital sign: Heart rate will be counted

  during the sedation procedure (from its onset till meeting discharge criteria)

• Hemodynamic response of sedative agents.

  Vital sign: Oxygen saturation will be monitored using an oximeter

  during the sedation procedure (from its onset till meeting discharge criteria)

Study Arms (3)

Midazolam group (MDZ)

ACTIVE COMPARATOR

Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.5 mg/kg Midazolam.

Drug: Midazolam group (MDZ)

Dexmedetomidine group (DEX)

EXPERIMENTAL

Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 5µg/kg Dexmedetomidine.

Drug: Dexmedetomidine group (DEX)

Combination of Midazolam and Dexmedetomidine (MDZ/DEX)

EXPERIMENTAL

Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.

Drug: Combination of Midazolam and Dexmedetomidine (MDZ/DEX)

Interventions

Midazolam group (MDZ) DRUG

IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland

Midazolam group (MDZ)

Dexmedetomidine group (DEX) DRUG

IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.

Dexmedetomidine group (DEX)

Combination of Midazolam and Dexmedetomidine (MDZ/DEX) DRUG

Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(

Combination of Midazolam and Dexmedetomidine (MDZ/DEX)

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age range 4-6 years
• Frankl scale score 2.
• ASA I or II physical status.
• Dental intervention under local anesthesia not requiring more than 30 minutes.
• No previous dental experience.
• Parent/guardian"s written consent.

You may not qualify if:

• Dental treatment indicated under general anesthesia.
• Presence of facial deformities.
• History of neurological or cognitive alterations.
• Mouth breathers.

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (15)

• Zanaty OM, El Metainy SA. A comparative evaluation of nebulized dexmedetomidine, nebulized ketamine, and their combination as premedication for outpatient pediatric dental surgery. Anesth Analg. 2015 Jul;121(1):167-171. doi: 10.1213/ANE.0000000000000728.

  PMID: 25822924 BACKGROUND

• Gomes HS, Miranda AR, Viana KA, Batista AC, Costa PS, Daher A, Machado GC, Sado-Filho J, Vieira LA, Correa-Faria P, Hosey MT, Costa LR. Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial. Trials. 2017 Apr 11;18(1):172. doi: 10.1186/s13063-017-1919-2.

  PMID: 28399933 BACKGROUND

• Guideline for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatr Dent. 2016 Oct 15;38(5):77-106.

  PMID: 28206886 BACKGROUND

• Tobias JD, Leder M. Procedural sedation: A review of sedative agents, monitoring, and management of complications. Saudi J Anaesth. 2011 Oct;5(4):395-410. doi: 10.4103/1658-354X.87270.

  PMID: 22144928 BACKGROUND

• Surendar MN, Pandey RK, Saksena AK, Kumar R, Chandra G. A comparative evaluation of intranasal dexmedetomidine, midazolam and ketamine for their sedative and analgesic properties: a triple blind randomized study. J Clin Pediatr Dent. 2014 Spring;38(3):255-61. doi: 10.17796/jcpd.38.3.l828585807482966.

  PMID: 25095322 BACKGROUND

• Singh C, Pandey RK, Saksena AK, Chandra G. A comparative evaluation of analgo-sedative effects of oral dexmedetomidine and ketamine: a triple-blind, randomized study. Paediatr Anaesth. 2014 Dec;24(12):1252-9. doi: 10.1111/pan.12493. Epub 2014 Jul 25.

  PMID: 25065424 BACKGROUND

• Li BL, Zhang N, Huang JX, Qiu QQ, Tian H, Ni J, Song XR, Yuen VM, Irwin MG. A comparison of intranasal dexmedetomidine for sedation in children administered either by atomiser or by drops. Anaesthesia. 2016 May;71(5):522-8. doi: 10.1111/anae.13407. Epub 2016 Mar 3.

  PMID: 26936022 BACKGROUND

• Harbuz DK, O'Halloran M. Techniques to administer oral, inhalational, and IV sedation in dentistry. Australas Med J. 2016 Feb 29;9(2):25-32. doi: 10.4066/AMJ.2015.2543. eCollection 2016.

  PMID: 26989448 BACKGROUND

• Greaves A. The use of Midazolam as an Intranasal Sedative in Dentistry. SAAD Dig. 2016 Jan;32:46-9.

  PMID: 27145560 BACKGROUND

• Bulach R, Myles PS, Russnak M. Double-blind randomized controlled trial to determine extent of amnesia with midazolam given immediately before general anaesthesia. Br J Anaesth. 2005 Mar;94(3):300-5. doi: 10.1093/bja/aei040. Epub 2004 Nov 26.

  PMID: 15567810 BACKGROUND

• Silva FC, Thuler LC. Cross-cultural adaptation and translation of two pain assessment tools in children and adolescents. J Pediatr (Rio J). 2008 Jul-Aug;84(4):344-9. doi: 10.2223/JPED.1809.

  PMID: 18688551 BACKGROUND

• Vernon DT, Schulman JL, Foley JM. Changes in children's behavior after hospitalization. Some dimensions of response and their correlates. Am J Dis Child. 1966 Jun;111(6):581-93. doi: 10.1001/archpedi.1966.02090090053003. No abstract available.

  PMID: 5939538 BACKGROUND

• Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.

  PMID: 2286697 BACKGROUND

• 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 BACKGROUND

• Canpolat DG, Yildirim MD, Aksu R, Kutuk N, Alkan A, Cantekin K. Intravenous ketamine, propofol and propofol-ketamine combination used for pediatric dental sedation: A randomized clinical study. Pak J Med Sci. 2016 May-Jun;32(3):682-7. doi: 10.12669/pjms.323.9834.

  PMID: 27375714 BACKGROUND

Related Links

• American Society of Anesthesiologists. ASA Physical Status Classification System.

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Amira A El-Khatib, MSc

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Nadia A Wahba, PhD

  Alexandria University

  STUDY DIRECTOR

• Karin ML Dowidar, PhD

  Alexandria University

  STUDY DIRECTOR

• Tamer AM Ghoneim, PhD

  Faculty of Medicine, Alexandria Univerity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researcher, statistician and participants will be blinded to the intervention group. Only the supervisor and the anesthesiologist will be aware of the allocation group. After data collection is completed, the randomization code will be broken to reveal the allocation group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Instructor

Model Details: The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 1, 2019
• Study Start: November 27, 2017
• Primary Completion: August 29, 2019
• Study Completion: December 22, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

EG (1)