Trial Outcomes & Findings for Decrease Emergence Agitation and Provide Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy (NCT NCT00468052)

Results Overview

emergence agitation and pain will be assessed. Pediatric Anesthesia Emergence Delirium Scale (PAED) range 0-20 a lower score indicates the child is calm and the higher score indicates severe agitation. Cole Agitation Scale was employed which is a 5 point Likert scale. Parameters ranging 1 to 5 1=child is calm and 5 =the child is severly agitated . Objective Pain Score range is 0-10 (higher score the greater pain). 3 Parameters are captured systolic b/p,crying, movements, agitation , complaints of pain

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

122 participants

Primary outcome timeframe

On arrival to PACU and 2 hours postoperatively

Results posted on

2016-12-05

Participant Flow

Recruitment period April 2007 to June 2009.Children recruited from the practice of the same pediatric otolaryngologist at UH in Newark. The study was introduced to the parent/legal guardian during the preoperative visit. Consent was obtained on the morning of surgery by a member of the pediatric anesthesiology study team.

None as long as the subject fit the inclusion criteria

Participant milestones

Participant milestones
Measure	Fentanyl (F) Group 61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established. 0	Dexmedetomidine 61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
Overall Study STARTED	68	69
Overall Study Target Enrollment	70	70
Overall Study COMPLETED	61	61
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Fentanyl (F) Group 61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established. 0	Dexmedetomidine 61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
Overall Study Protocol Violation	7	8

Baseline Characteristics

Decrease Emergence Agitation and Provide Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fentanyl (F) Group n=61 Participants 61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established. 0	Dexmedetomidine n=61 Participants 61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr	Total n=122 Participants Total of all reporting groups
Age, Categorical <=18 years	61 Participants n=5 Participants	61 Participants n=7 Participants	122 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	3.8 years STANDARD_DEVIATION 1.5 • n=5 Participants	4.2 years STANDARD_DEVIATION 2.1 • n=7 Participants	4.0 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants	61 participants n=7 Participants	122 participants n=5 Participants

PRIMARY outcome

Timeframe: On arrival to PACU and 2 hours postoperatively

Population: per protocol, OPS, PAED and Cole scale are expressed as median values of the maximum score

emergence agitation and pain will be assessed. Pediatric Anesthesia Emergence Delirium Scale (PAED) range 0-20 a lower score indicates the child is calm and the higher score indicates severe agitation. Cole Agitation Scale was employed which is a 5 point Likert scale. Parameters ranging 1 to 5 1=child is calm and 5 =the child is severly agitated . Objective Pain Score range is 0-10 (higher score the greater pain). 3 Parameters are captured systolic b/p,crying, movements, agitation , complaints of pain

Outcome measures

Outcome measures
Measure	Fentanyl (F) Group n=61 Participants 61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established. 0	Dexmedetomidine n=61 Participants 61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
Emergence Agitation and Pain PAED	14 units on a scale Interval 0.0 to 20.0	10 units on a scale Interval 0.0 to 20.0
Emergence Agitation and Pain Cole EA	4 units on a scale Interval 1.0 to 5.0	3 units on a scale Interval 1.0 to 5.0
Emergence Agitation and Pain OPS	5 units on a scale Interval 0.0 to 10.0	3 units on a scale Interval 0.0 to 10.0

PRIMARY outcome

Timeframe: on arrival to PACU and for 2 hours postoperatively

Cole EA scale 1=calm , 5=unconsolable

Outcome measures

Outcome measures
Measure	Fentanyl (F) Group n=61 Participants 61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established. 0	Dexmedetomidine n=61 Participants 61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
Duration of Agitation	11.85 minutes Standard Deviation 12.02	6.59 minutes Standard Deviation 7.42

SECONDARY outcome

Timeframe: intraoperatively

Participants whose heart rate per minute was below 60 intraoperatively. Participants whose systolic blood pressure dremonstrated \< 30% decrease from baseline and sustained for 5 minutes received rescue as defined by the protocol.

Outcome measures

Outcome measures
Measure	Fentanyl (F) Group n=61 Participants 61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established. 0	Dexmedetomidine n=61 Participants 61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
Hemodynamic Stability heart rate below 60 bpm	0 participants	0 participants
Hemodynamic Stability systolic blood pressure <30% below baseline	0 participants	0 participants

SECONDARY outcome

Timeframe: at end of surgery

Population: per protocol

defined as spontaneous eye opening or on command

Outcome measures

Outcome measures
Measure	Fentanyl (F) Group n=61 Participants 61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established. 0	Dexmedetomidine n=61 Participants 61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
Time to Awaken	8.75 minutes Standard Deviation 4.06	7.18 minutes Standard Deviation 4.05

SECONDARY outcome

Timeframe: at end of surgical procedure

Population: per protocol

defined as time from end of surgery to tracheal extubation

Outcome measures

Outcome measures
Measure	Fentanyl (F) Group n=61 Participants 61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established. 0	Dexmedetomidine n=61 Participants 61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
Time to Extubation	10.44 minutes Standard Deviation 4.15	8.59 minutes Standard Deviation 4.51

SECONDARY outcome

Timeframe: on arrival to PACU and 2 hours postoperatively

Outcome measures

Outcome measures
Measure	Fentanyl (F) Group n=61 Participants 61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established. 0	Dexmedetomidine n=61 Participants 61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
Number of Participants With SpO2 < or Equal to 95%	2 participants	4 participants

SECONDARY outcome

Timeframe: arrival in PACU to 2 hours postoperatively

Outcome measures

Outcome measures
Measure	Fentanyl (F) Group n=61 Participants 61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established. 0	Dexmedetomidine n=61 Participants 61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
Participants Requiring Morphine Rescue in PACU	25 participants	11 participants

Adverse Events

Fentanyl (F) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexmedetomidine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fentanyl (F) Group n=61 participants at risk No subjects in group F experienced an adverse event. 0	Dexmedetomidine n=61 participants at risk 1 subjects Group D experienced an adverse event.
Respiratory, thoracic and mediastinal disorders pulmonary edema	0.00% 0/61 • 24 hours. At the end of surgery but prior to extubation the subject demonstrated symptoms of pulmonary edema. She was treated with lasix, chest x-ray done. It was elected to keep the pt intubated overnight in an ICU unit. She was extubated the following day and did very well.	1.6% 1/61 • Number of events 1 • 24 hours. At the end of surgery but prior to extubation the subject demonstrated symptoms of pulmonary edema. She was treated with lasix, chest x-ray done. It was elected to keep the pt intubated overnight in an ICU unit. She was extubated the following day and did very well.

Other adverse events

Adverse event data not reported

Additional Information

Anuradha Patel, MD

UMDNJ

Phone: 973 972-5254

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place