Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics

Ain Shams University

Status and phase: Completed; Phase 1

Conditions: Vital Signs

Treatments: Drug: Ketamine/ propofol; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04678050

IRB 000-6379

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 5 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups

group I received ketamine/propofol (ketofol) solution

Active Comparator group

Description:

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.

Treatment:

Drug: Ketamine/ propofol

group II received the Dex solution (4 µg/mL

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine