Intranasal Dexmedetomidine Premedication in Children
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 5 - 19 |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | December 2015 |
| Contact: | Madhankumar Sathyamoorthy, MBBS, MS |
| Email: | msathyamoorthy@umc.edu |
| Phone: | 6035664660 |
Comparing Intranasal Dexmedetomidine With Oral Midazolam as Premedication for Older Children Undergoing General Anesthesia for Dental Rehabilitation
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.
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.
After 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 .
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 .
Inclusion Criteria:
- Children older than 5yrs and weighing more than 20kg , who are scheduled for
ambulatory dental rehabilitation at Batson operating rooms.
- ASA classification 1 or 2
Exclusion Criteria
- Known allergy to midazolam, dexmedetomidine,morphine, fentanyl, sevoflurane and
propofol.
- uncorrected congenital heart disease or history of cardiac arrhythmia,
- children at risk for airway obstruction (OSA or cranio facial syndrome),
- pregnant minors
We found this trial at
1
site
Jackson, Mississippi 39216
Principal Investigator: Madhankumar Sathyamoorthy, MBBS, MS
Phone: 603-566-4660
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