Trial Outcomes & Findings for Intranasal Dexmedetomidine Premedication in Children (NCT NCT02250703)

Results Overview

Level of sedation at separation from parents and at the time of mask induction will be measured on a scale of 0 to 4 (University of Michigan Sedation Scale) University of Michigan Sedation Scale: 0 -Awake/Alert 1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation. 4 - Unarousable Moderately and Deeply sedated: Satisfactory Awake, minimally sedate, unarousable: Unsatisfactory

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

75 participants

Primary outcome timeframe

Day 0:Just before the patient will be brought to the operating room

Results posted on

2017-07-07

Participant Flow

Participant milestones

Participant milestones
Measure	Midazolam 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 as premedication Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg	Dexmedetomidine 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). Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg
Overall Study STARTED	38	37
Overall Study COMPLETED	37	36
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intranasal Dexmedetomidine Premedication in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Midazolam n=37 Participants 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 as premedication Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg	Dexmedetomidine n=36 Participants 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). Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg	Total n=73 Participants Total of all reporting groups
Age, Categorical <=18 years	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	7.62 years STANDARD_DEVIATION 2.3 • n=5 Participants	8.0 years STANDARD_DEVIATION 3.37 • n=7 Participants	7.9 years STANDARD_DEVIATION 3.1 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment United States	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0:Just before the patient will be brought to the operating room

Level of sedation at separation from parents and at the time of mask induction will be measured on a scale of 0 to 4 (University of Michigan Sedation Scale) University of Michigan Sedation Scale: 0 -Awake/Alert 1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation. 4 - Unarousable Moderately and Deeply sedated: Satisfactory Awake, minimally sedate, unarousable: Unsatisfactory

Outcome measures

Outcome measures
Measure	Midazolam n=37 Participants 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 as premedication Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg	Dexmedetomidine n=36 Participants 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). Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg
University of Michigan Sedation Scale Satisfactory sedation on separation from parents	15 Participants	25 Participants
University of Michigan Sedation Scale Unsatisfactory sedation on separation from parents	22 Participants	11 Participants
University of Michigan Sedation Scale Satisfactory sedation on transfer to OR table	12 Participants	22 Participants
University of Michigan Sedation Scale Unsatisfactory sedation on transfer to OR table	25 Participants	14 Participants

SECONDARY outcome

Timeframe: Day 0: At the time when anesthesia is induced

on a scale of 1 to 4 1. excellent( cooperative) 2. good( slight fear, easily calmed) 3. fair ( moderate fear, not calmed with reassurance) 4. Poor( agitated, terrified) 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory

Outcome measures

Outcome measures
Measure	Midazolam n=37 Participants 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 as premedication Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg	Dexmedetomidine n=36 Participants 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). Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg
Acceptance of Mask Induction Satisfactory mask induction	35 Participants	29 Participants
Acceptance of Mask Induction unsatisfactory mask induction	2 Participants	7 Participants

SECONDARY outcome

Timeframe: Day 0: At the end of surgery when the patient recovers from anesthesia

assessed in post anesthesia recovery unit after the procedure on a scale of 1o 4 1. calm 2. not calm but easily calmed 3. moderately agitated or restless 4. combative/disoriented 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory

Outcome measures

Outcome measures
Measure	Midazolam n=37 Participants 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 as premedication Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg	Dexmedetomidine n=36 Participants 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). Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg
Wake up Behavior satisfactory wake up behavior	37 Participants	35 Participants
Wake up Behavior unsatisfactory wake up behavior	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 0: at the time of discharge of the patient from the recovery room

Population: 7 patients in the M group and 5 patients in D group had significant developmental delay and could not answer the question regarding memory of mask induction. Thus, only 61 were analyzed for this part

Yes or No (if the patient remembers mask induction)

Outcome measures

Outcome measures
Measure	Midazolam n=30 Participants 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 as premedication Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg	Dexmedetomidine n=31 Participants 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). Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg
Presence of Amnesia to Mask Induction memory of mask induction-yes	6 Participants	5 Participants
Presence of Amnesia to Mask Induction memory of mask induction-no	24 Participants	26 Participants

Adverse Events

Midazolam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Madhankumar Sathyamoorthy. PI

University of Mississippi Medical Center

Phone: 6018157066

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place