Intranasal Dexmedetomidine Premedication in Children
Condition: Preoperative Sedation
Study type: Interventional
Phase: Phase 3

Summary: 
      BACKGROUND INFORMATION AND RATIONALE

      Pediatric patients scheduled for dental procedures under general anesthesia can have
      significant anxiety before the procedure. They are commonly pre medicated to minimize
      distress and to facilitate a smooth induction of anesthesia. Oral Midazolam at 0.5mg/kg dose
      is more widely used for this purpose . However the commonly used maximum dose is up to 15mg.
      It also has many limitations such as paradoxical reaction, increased incidence of emergence
      delirium and negative postoperative behavior changes . Intranasal dexmedetomidine has been
      used an effective and safe alternative premedication to oral midazolam in children. At a dose
      of 2micrograms/kg, intranasal dexmedetomidine as premedication resulted in excellent sedation
      in children aged 5-8yrs with no adverse hemodynamic effects. It has other advantages such as
      providing analgesia and facilitating smooth emergence from anesthesia.

      The goal of this study is to find out if intranasal dexmedetomidine is a superior alternative
      as premedication to oral midazolam in children weighing more than 20kg undergoing general
      anesthesia for dental rehabilitation.
    

Detailed description: 
      After Institutional Review Board (IRB) approval and written informed consent from patients'
      parents or legally authorized representative, 80 children older than 5yrs and weighing more
      than 20kg, ASA physical status 1 or 2, scheduled for elective dental rehabilitation with
      general anesthesia will be enrolled in this prospective randomized double blinded study.

      Exclusion criteria include known allergy or hypersensitivity to midazolam or dexmedetomidine,
      uncorrected congenital heart disease or history of cardiac arrhythmia, children at risk for
      airway obstruction (OSA or cranio facial syndrome) and pregnant minors Patients will be
      randomly assigned to one of two groups M (midazolam) or D (dexmedetomidine) using
      computer-generated numbers in sealed envelopes.

      All the patients will be brought to their pre-op room and premedicated at least 30 min before
      induction of anesthesia.

      In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml
      parenteral preparation) mixed with flavored syrup.

      In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of
      100mcg prepared from 100mcg/ml parenteral preparation (Hospira R). The drug will be
      administered using a intranasal mucosal administration device (LMA MAD NasalTM). Atomized
      nasal medications offer rapid absorption across mucosal membranes to the blood stream
      avoiding first-pass metabolism.

      Parents will be present in the room during premedication. The Anesthesia personnel involved
      in the care of the patient (MD or CRNA) will prepare and administer all study drugs. All
      patients will be continuously monitored in the holding area with pulse oximetry and blood
      pressure monitor. HR, SPO2 and BP will be recorded every 15min after administration of
      premedication until transfer to the OR. Emergency medications including atropine and
      epinephrine will be immediately available in the pre-op holding area. Oral midazolam has been
      used with very little effect on hemodynamic parameters. Although intranasal dexmedetomidine
      can decrease HR and BP, it has been used at the dose of 2mcg/kg without any adverse
      hemodynamic effect . Any intervention needed to treat drop in HR (<50) and BP (sys BP <60)
      after the drug administration will be recorded.

      Behavior of the children at the time of premedication will be documented ( easy or
      difficult). Any unwanted effects during administration such as spitting or vomiting of oral
      drug and pain or irritation from nasal administration will be documented.

      The dental resident blinded to study drug administration will do the pre-operative sedation
      status and acceptance of mask induction.

      Sedation status will be assessed using University of Michigan sedation scale (UMSS)on
      separation from parents and at induction after moving to the OR table. Acceptance of mask
      induction will be documented on a 4-point scale.

      Standard ASA monitors will be applied before induction of anesthesia. All patients will
      undergo mask induction with O2/N2O/Sevo. An intravenous line will be inserted and secured.
      Both nostrils will be prepped nasal drops and tips of tracheal tubes covered with red rubber
      to minimize bleeding. Nasal intubation will be performed with direct laryngoscopy and
      McGill's forceps. Appropriate size cuffed tracheal tubes will be inserted and secured after
      additional IV medications with propofol 2-3mg/kg and fentanyl 1-2mcg/kg. Anesthesia will be
      maintained with O2/Sevo, IV morphine 0.05 to 0.1mg/kg and IV toradol 0.5mg/kg (if there is no
      allergy or contraindication to morphine or toradol) After the completion of procedure,
      patients will be extubated in the operating room and brought to recovery room and allowed to
      wake up slowly in the recovery position.

      PACU nurses will evaluate Behavior at awakening using four-point wake up score (9,20).
      Patients will also be asked if they remember mask induction (yes or no) when they are ready
      for discharge. Incidence of nausea, vomiting, shivering will be documented in PACU. Time
      spent in phase 1 recovery room will also be recorded .
    

Intervention name(s): Midazolam; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): oral midazolam 0.5mg/kg upto maximum dose of 15mg; intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Premedication