Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics

Ain Shams University40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Vital Signs

Interventions

Ketamine/ propofolDRUG

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.

DexmedetomidineDRUG

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ain Shams University

Cairo, Abassia, Egypt

Outcomes

Primary Outcomes

the Number of interruptions

the Number of interruptions that occurred during the procedure

Time frame: through study completion, an average of 3 month

Secondary Outcomes

total dose of rescue drug

total dose of rescue propofol in mg

Time frame: through study completion, an average of 3 month

Data from ClinicalTrials.gov

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