Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics

Phase 1

Completed

• Conditions: Vital Signs
• Interventions: Drug: Ketamine/ propofol; Drug: Dexmedetomidine

• Registration Number: NCT04678050
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2020-10-10
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-21
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group I received ketamine/propofol (ketofol) solution	Ketamine/ propofol	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.
group II received the Dex solution (4 µg/mL	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
the Number of interruptions	through study completion, an average of 3 month	the Number of interruptions that occurred during the procedure

Secondary Outcome Measures

Name	Time	Method
total dose of rescue drug	through study completion, an average of 3 month	total dose of rescue propofol in mg

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Abassia, Egypt