Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics

NCT ID: NCT04678050

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-10
• Study Completion Date: 2021-12-30

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.

Conditions

Vital Signs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

group I received ketamine/propofol (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.

Group Type: ACTIVE_COMPARATOR

Ketamine/ propofol

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Ketofol; precedex

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Rania Maher Hussien, MD

Lecturer of Anaesthesia and intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa Ismail, MD

Role: STUDY_CHAIR

Head of research ethics committee

Locations

Ain Shams University

Cairo, Abassia, Egypt

Countries

Egypt

Other Identifiers

IRB 000-6379

Identifier Type: -

Identifier Source: org_study_id