Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202105602764595 Date of Registration: 27/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Buccal Administration of Dexmedetomidine - Ketamine Combination for Sedation of Pediatric Dental Patients (A Randomized Controlled Trial)
Official scientific title Effectiveness of Buccal Administration of Dexmedetomidine - Ketamine Combination for Sedation of Pediatric Dental Patients (A Randomized Controlled Trial)
Brief summary describing the background and objectives of the trial Background: The prevalence of fear and anxiety toward dentistry has been documented as the main obstacle, which could make pediatric patients avoid seeking the required dental care. In some cases, managing anxious children pose a considerable challenge to pediatric dentist. Pharmacological agents that produce moderate sedation come into help in such uncooperative patients. Purpose: The aim of the study is to evaluate and compare the effectiveness of buccal administration of Dexmedetomidine-ketamine combination and Dexmedetomidine for sedation of uncooperative pediatric dental patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/08/2021
Actual trial start date
Anticipated date of last follow up 20/01/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combination of Dexmedetomidine and Ketamine group 2μg/kg Dexmedetomidine and 2 mg/kg ketamine Not more than 30 minutes Dental intervention under local anesthesia not requiring more than 30 minutes for uncooperative pediatric dental patients aged from 3 to 5 years with American Society of Anesthesiologists I or II status. 26
Control Group Dexmedetomidine group 4μg/kg DEX Not more than 30 minutes Dental intervention under local anesthesia not requiring more than 30 minutes for uncooperative pediatric dental patients aged from 3 to 5 years with American Society of Anesthesiologists I or II status. 26 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients with an age ranging between 3-5 year old. • Frankl scale score 1 or 2 (Definitely Negative or Negative behavior) for whom all non-pharmacological behavior management failed to gain their compliance . • American Society of Anesthesiologist physical status of type I, II. • Dental intervention under local anesthesia not requiring more than 30 minutes. • Parent/guardian written consent. • Patients who need extensive dental treatment requiring general anesthesia. • Patients with known allergy to ketamine or dexmedetomidine. • Medically compromised patients. • Cognitively impaired patients. Preschool Child: 2 Year-5 Year 3 Year(s) 5 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/03/2021 Ethical committee of Alexandria university
Ethics Committee Address
Street address City Postal code Country
Champolion Alexandria 00203 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome (drug effectiveness) will be assessed through: 1- Analgo-sedative effect of each drug - Onset of Sedation will be recorded in minutes. - The analgesic effect of the sedative drugs will be assessed during L.A. administration using ‘Face, Legs, Activity, Cry, Consolability’ scale “FLACC”. - Sedation level: Using Observer’s Assessment of Alertness/Sedation Scale. - The duration of sedation will be recorded in minutes. - Procedural side effects (hypoxia, agitation, bradycardia, hypotension, vomiting, etc) will be recorded during the procedure. 2- Behaviour response to drug delivered - Post-operative effects of the sedation will be assessed using child behavior questionnaire according to Modified Vernon et al. - Child’s behavior in the follow-up sessions will be reassessed and compared to that at baseline (before dental treatment) using Frankl scale. Sedation level will be measured at optimum sedation and will be reassessed during the operative procedure
Secondary Outcome - The ‘ease of treatment completion’ will be measured using separate five-point scales. - Amnesic effect of sedative agents. Anterograde amnesia: will be assessed according to a modification of Bulach et al. - Hemodynamic response of sedative agents will be recorded. (SBP, DBP, HR, and saO2). - Procedural-induced stress will be assessed in children by measuring salivary sIgA levels. outcomes will be measured during and after dental treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Dentistry Alexandria University Champolion Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sara Elrouby 17 Zaki Ragab street, Smouha Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sara Elrouby 17 Zaki ragab street, Smouha Alexandria Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sara Elrouby elroby.sara@gmail.com 00201008383552 17 zaki ragab street , Smouha
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant lecturer at faculty of dentistry
Role Name Email Phone Street address
Scientific Enquiries Magda Eltekeya magdatekeya@hotmail.com 00201122299960 18 Elpharaana street,Elshalalat
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Pediatric Dentistry and Dental Public Health
Role Name Email Phone Street address
Public Enquiries Hams Abdelrahman hamshamed14@gmail.com 00201009374588 Azarita
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant lecturer of DPH
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Undecided: It is not yet known if there will be a plan to make IPD available. Approval should be obtained from the faculty's research committee first after finishing the study. Study Protocol It may be available starting 3 to 6 months after publication Anyone could access the documents through emailing the main investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information