Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics

Vital Signs Clinical Trial

Official title:

Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics Undergoing Dental Procedures: a Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04678050
• Other study ID #: IRB 000-6379
• Status: Completed
• Phase: Phase 1
• Start date: October 10, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 30, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Vital Signs

Intervention

Drug:
• 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.
• Dexmedetomidine
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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo	Abassia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Number of interruptions	the Number of interruptions that occurred during the procedure	through study completion, an average of 3 month
Secondary	total dose of rescue drug	total dose of rescue propofol in mg	through study completion, an average of 3 month