Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics
Condition: Vital Signs
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Ketamine/ propofol; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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
Other intervention name(s): Ketofol; precedex
Intervention MeSH terms: Dexmedetomidine; Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care