Clinical trial NCT04678050: Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics
Official title: Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics Undergoing Dental Procedures: a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vital Signs
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study participants will be allocated into two equal groups. Subjects in group I will receive ketofol solution (ketamine/propofol mixture, each mL contains 5 mg of ketamine plus 10 mg of propofol). A loading dose of 0.125 mL/kg will be administered intravenously (IV) over 10 min, followed by maintenance infusion at a rate of 0.05-0.125 mL/kg/h. Subjects in group II will receive the Dex solution (4 µg/mL). A loading dose of 2 µg/kg will be administered IV over 10 min, followed by a maintenance infusion of 0.1-1 µg/kg/h. Non-invasive blood pressure (mean ABP) peripheral oxygen saturation, heart rate, and respiratory rate will be assessed at baseline, at 2 minutes, then at 5 minutes intervals till 60 minutes. Ramsay sedation and Aldrete's recovery rating scores were assessed before, during, and after the procedure.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Dental fear and anxiety remain common problems that should be managed by both the dentist and the anesthetist. The currently available evidence for safe and effective sedative drugs for children undergoing the dental procedure is scarce The aim of this study was to compare the safety and efficacy of intravenous ketofol versus dexmedetomidine (Dex) as premedications a sedative in anxious children undergoing dental pulp therapy

Detailed description: This double-blind, parallel-group, randomized clinical study will recruiter anxious children who will undergo dental pulp therapy. The study participants will be allocated into two equal groups. Subjects in group I will receive ketofol solution (ketamine/propofol mixture, each mL contains 5 mg of ketamine plus 10 mg of propofol). A loading dose of 0.125 mL/kg will be administered intravenously (IV) over 10 min, followed by maintenance infusion at a rate of 0.05-0.125 mL/kg/h. Subjects in group II will receive the Dex solution (4 µg/mL). A loading dose of 2 µg/kg will be administered IV over 10 min, followed by a maintenance infusion of 0.1-1 µg/kg/h. Non-invasive blood pressure (mean ABP), peripheral oxygen saturation, heart rate, and respiratory rate will be assessed at baseline, at 2 minutes, then at 5 minutes intervals till 60 minutes. Ramsay sedation and Aldrete's recovery rating scores will be assessed before, during, and after the procedure.

Eligibility criteria: Inclusion Criteria:

* ASA-I children,
* aged 5-10 years-old,
* requiring dental pulp therapy

Exclusion Criteria:

* ASA class ≥ II;
* previous experience with GA or Conscious sedation (CS);
* dental treatment expected to exceed 45 minutes;
* history of allergy to local anesthetics, Dex, propofol, ketamine, eggs, or soya;
* respiratory tract infections

Primary outcomes:
measure: the Number of interruptions
timeFrame: through study completion, an average of 3 month
Secondary outcomes:
measure: total dose of rescue drug
timeFrame: through study completion, an average of 3 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abassia
Study officials:
affiliation: Head of research ethics committee
name: Alaa Ismail, MD
role: STUDY_CHAIR
References: