Comparison of Nebulized Fentanyl, Midazolam and Dexmedetomidine as a Premedication in Pediatric Dental Surgeries
Condition: Dental Surgeries
Study type: Interventional

Summary: 
      -  The preoperative time can be traumatic for young children undergoing surgery. Pediatric
           anesthesiologists act strongly to decrease distress for children in the operating room
           (OR) and to provide a smooth induction of anesthesia.

        -  Many drugs have been used as premedication to decrease anxiety , facilitate smooth
           induction and easy separation of children from their parents.

        -  This study was designed to evaluate and compare the effect and safety of nebulized
           either fentanyl, midazolam or nebulized dexmedetomidine as a sedative premedication
           prior to general anesthesia (GA) in outpatient pediatric dental surgeries.
    

Detailed description: 
      The preoperative time can be traumatic for young children undergoing surgery. Pediatric
      anesthesiologists act strongly to decrease distress for children in the operating room (OR)
      and to provide a smooth induction of anesthesia(1). Parentral separation and needle injection
      increase preoperative anxiety. Preoperative stress response stimulates the sympathetic,
      parasympathetic, and endocrine systems, leading to an increase in heart rate (HR), blood
      pressure, and cardiac excitability(2,3) . Dental procedures are assiociated by high rate of
      fear and anxiety in children (4).

      Many drugs have been used as premedication to decrease anxiety , facilitate smooth induction
      and easy separation of children from their parents. The ideal premedication especially in
      children must be acceptable with rapid onset ,minimal side effects and with rapid
      postoperative recovery and return to alertness (5,6).

      Fentanyl is a potent analgesic opioid with a rapid onset, and short duration of action (7).
      Midazolam is a short-acting benzodiazepine that has anxiolytic, amnestic, hypnotic,
      anticonvulsant and muscle relaxant actions (8,9). Dexmedetomidine is a selective α-2
      adrenergic agonist that has both sedative and analgesic effects (10-12)

      Preoperative sedation in children is usually administered via the rectal, oral sublingual,
      and intranasal routes with different degrees of patient acceptance.(13-18). Nebulized drug is
      an alternative method of sedation that is relatively easy to set up, without need for
      venipuncture, and is associated with high bioavailability of the drug (19,20).

      This study was designed to evaluate and compare the effect and safety of nebulized either
      fentanyl, midazolam or nebulized dexmedetomidine as a sedative premedication prior to general
      anesthesia (GA) in outpatient pediatric dental surgeries. The primary end point is the time
      of sedation and level of sedation when the child is first seen in the operating room(OR) 30
      minutes after using studied drugs, based on the Modified Observer's Assessment of
      Alertness/Sedation Scale(19). The secondary end points are parentral separation, tolerance to
      mask induction, reaction to intravenous cannulation, hemodynamic changes( systolic blood
      pressure, diastolic blood pressure and heart rate), sedation at emergence and wake-up
      behavior.
    

Intervention name(s): fentanyl; midazolam; dexmedetomidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): nebulized fentanyl 2μg/kg body weigh; nebulized midazolam 0.2 mg/kg body weight 30 min before surgery.; nebulized dexmedetomidine 2 μg/kg body weight 30 min before surgery.
Other intervention name(s): fentanyl,; dormicum; precedex
Intervention MeSH terms: Midazolam; Fentanyl; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fentanyl ,midazolam, dexmeditomidine