Trial Outcomes & Findings for Effect of Dexmedetomidine on Emergence Agitation in Children With or Without Tube Insertion Under General Anesthesia (NCT NCT01535287)

Results Overview

The aim/measurement of the study is to determine whether or not a single IM injection of Dexmedetomidine will reduce the severity of Emergent Agitation (EA) in children undergoing Bilateral Myringotomy with/without tubes under general anesthesia. We used the only validated scale to assess the severity of post operative emergence delirium in pediatrics. This Pediatric Anesthesia Emergence Delirium (PAED) scale is a composite score of the following items: 1. Makes eye contact with caregiver. 2. Child's actions are purposeful. 3. Child aware of his/her surroundings. 4. The child is restless. 5. The child is inconsolable. Items 1, 2, and 3 are reversed scored as follows: 4-not at all, 3-a little, 2-quite a bit, 1-very much, 0-extremely. Items 4 and 5 are scored as follows: 0-not at all, 1-a little, 2-quite a bit, 3-very much, 4-extremely. The total score will range from 0 to 20; with 0 indicating no emergence delirium and 20 indicating extreme emergence delirium.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

140 participants

Primary outcome timeframe

Participants will be followed for the duration of first PACU recovery step, an expected average visit of 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia.

Results posted on

2018-07-09

Participant Flow

Participant milestones

Participant milestones
Measure	Dexmedetomidine Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.	Placebo Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.
Overall Study STARTED	70	70
Overall Study COMPLETED	65	64
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Dexmedetomidine Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.	Placebo Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.
Overall Study drug not prepared in time	5	6

Baseline Characteristics

Effect of Dexmedetomidine on Emergence Agitation in Children With or Without Tube Insertion Under General Anesthesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine n=65 Participants Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.	Placebo n=64 Participants Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.	Total n=129 Participants Total of all reporting groups
Age, Categorical <=18 years	65 Participants n=5 Participants	64 Participants n=7 Participants	129 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	37 month STANDARD_DEVIATION 26 • n=5 Participants	39 month STANDARD_DEVIATION 30 • n=7 Participants	38 month STANDARD_DEVIATION 30 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	32 Participants n=7 Participants	67 Participants n=5 Participants
Region of Enrollment United States	65 participants n=5 Participants	64 participants n=7 Participants	129 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants will be followed for the duration of first PACU recovery step, an expected average visit of 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia.

The aim/measurement of the study is to determine whether or not a single IM injection of Dexmedetomidine will reduce the severity of Emergent Agitation (EA) in children undergoing Bilateral Myringotomy with/without tubes under general anesthesia. We used the only validated scale to assess the severity of post operative emergence delirium in pediatrics. This Pediatric Anesthesia Emergence Delirium (PAED) scale is a composite score of the following items: 1. Makes eye contact with caregiver. 2. Child's actions are purposeful. 3. Child aware of his/her surroundings. 4. The child is restless. 5. The child is inconsolable. Items 1, 2, and 3 are reversed scored as follows: 4-not at all, 3-a little, 2-quite a bit, 1-very much, 0-extremely. Items 4 and 5 are scored as follows: 0-not at all, 1-a little, 2-quite a bit, 3-very much, 4-extremely. The total score will range from 0 to 20; with 0 indicating no emergence delirium and 20 indicating extreme emergence delirium.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=65 Participants Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.	Placebo n=64 Participants Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.
Participant's Severity of Emergent Agitation (EA) Using the Pediatric Anesthesia Emergence Delirium (PAED) Scale in PACU (Post-Op Area).	7 units on a scale Standard Deviation 6	8 units on a scale Standard Deviation 6

SECONDARY outcome

Timeframe: Participants will be followed immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia.

Duration of stay in the PACU (Post-Op Area) until discharge criteria are met based on modified PADSS score: level of consciousness, physical activity, hemodynamic stability, respiratory stability, oxygen saturation status, post-operative pain, and post-operative emetic symptoms. Duration of time will be measured in total minutes participate is in PACU until discharged.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=65 Participants Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.	Placebo n=64 Participants Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.
Duration of Stay in PACU	21 minutes Standard Deviation 9	17 minutes Standard Deviation 7

SECONDARY outcome

Timeframe: Participants will be followed for the duration immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.

Postoperative adverse respiratory events: moderate to severe coughing, oxygen desaturation (SPO2 \<90%), breath holding, bronchospasm, aspiration, stridor and/or laryngospasm during PACU duration to discharge. The adverse respiratory events and the adverse hemodynamic events will be documented by the anesthesia provider in the operating room and by the recovery room nurses in the PACU recovery room. All will be blinded to the drug administered. Measurement will be obtained by "yes"/"no" to each possible adverse respiratory event by anesthesia staff.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=65 Participants Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.	Placebo n=64 Participants Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.
Respiratory Complications Peri-Operative	0 events Standard Error 0	0 events Standard Error 0

SECONDARY outcome

Timeframe: Participants will be followed for the duration immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.

Postoperative adverse hemodynamic events: bradycardia-a decrease in heart rate, hypotension-a decrease in systolic blood pressure (both determined as a 30% decrease from baseline) during PACU duration to discharge. The adverse hemodynamic events will be documented by the anesthesia provider in the operating room and by the recovery room nurses in the PACU recovery room. All will be blinded to the drug administered.Measurement will be obtained by "yes"/"no" to each possible adverse respiratory event by anesthesia staff.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=65 Participants Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.	Placebo n=64 Participants Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.
Hemodynamic Instability	0 events Standard Deviation 0	0 events Standard Deviation 0

SECONDARY outcome

Timeframe: Participants will be followed for the duration immediately following surgery, approximately 30 minutes, through approximately Day 3 post-surgery. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.

Behavioral disturbances analyzed are: sleep disturbances, anxiety, eating disturbances. These post-operative behavioral disturbances are not considered an adverse event. Data regarding postoperative behavioral disturbances will be collected by a blinded individual in a telephone interview 3 days after the surgery. Any "other adverse event" (not including serious) will also be documented by the telephone interview. Measurement will be obtained by "yes"/"no" to each possible AE by staff based on parent(s) response. "Other adverse events" (not including serious) reported immediately post-operatively includes: 1. allergic reaction to medication, 2. Respiratory distress, 3. Bronchospasms 4. Laryngospasm, 5. Hemodynamic instability

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=65 Participants Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.	Placebo n=64 Participants Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.
Post-Operative Behavioral Disturbances	9 events	10 events

SECONDARY outcome

Timeframe: Participants will be followed for the duration immediately following surgery, approximately 30 minutes, through approximately Day 3 post-surgery. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.

Postoperative muscle pain or swelling at the drug injection site. The duration of the stay in the PACU will be retrospectively documented by the research team using EPIC. Data regarding postoperative muscle pain or swelling will be collected by a blinded individual in a telephone interview 3 days after the surgery. Any adverse event will also be documented by the telephone interview. Measurement will be obtained by "yes"/"no" by staff based on parent(s) response.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=65 Participants Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.	Placebo n=64 Participants Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation. Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.
Muscle Pain	0 events	0 events

Adverse Events

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Martin Mueller

University of Iowa

Phone: 3193562633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place