Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics

Ketamine

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

Intervention / Treatment

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 were assessed before, during, and after the procedure.
  • Ketamine/ propofol (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.
  • Dexmedetomidine (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

Condition or Disease

  • Vital Signs

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 5 Years to 10 Years
    Enrollment: 40 (ACTUAL)
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    The pedo-dentist, the independent observer/data collector, and participants will be blind to the type of intervention. The study drugs will be prepared by an anesthesiologist who will not participate in the observation of the data. All the lines and syringes will be wrapped to mask colors of the sedative drugs, and the syringes will be label coded.

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Oct 10, 2020 ACTUAL
    Primary Completion: Dec 10, 2021 ACTUAL
    Completion Date: Dec 30, 2021 ACTUAL
    Study First Posted: Dec 21, 2020 ACTUAL
    Last Updated: Aug 04, 2022

    Sponsors / Collaborators

    Lead Sponsor: Ain Shams University
    Responsible Party: N/A

    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.

    Participant Groups

    • 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.

    • 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 Criteria

    Sex: All
    Minimum Age: 5
    Maximum Age: 10
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • the Number of interruptions that occurred during the procedure

    Secondary Outcomes

    • total dose of rescue propofol in mg

    More Details

    NCT Number: NCT04678050
    Other IDs: IRB 000-6379
    Study URL: https://clinicaltrials.gov/study/NCT04678050
    Last updated: Sep 29, 2023