TonsillectomyPhase 3NCT01528891

Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

A Phase 3 study testing Dexmedetomidine in people with Tonsillectomy, run by Peter Davis at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus Injection of Dexmedetomidine. Read more about this study

Who is it for?: Ages 4 to 10 years
Conditions the study is for: Tonsillectomy
What is being tested?: Dexmedetomidine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 418 participants
Where: 2 sitesUnited States
Study dates: Jan 2012to Aug 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion
ASA 1,2,3
females who have started menses but have a negative urine pregnancy test

Who cannot join

patients with known dysrhythmias,
not recovering in the ICU
developmental delay,
autism communication disorder
bleeding disorder
PI discretion

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224

Other trials in United States

About this study

Official title: Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children

Conditions: Tonsillectomy
Being tested: Dexmedetomidine, Placebo
Keywords: tonsillectomy, emergence agitation
Medical subject headings: Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
Also called Precedex
0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
PlaceboOther

Study groups in NCT01528891
Study group	Role	What they receive
Dexmedetomidine	Active comparator	Dexmedetomidine Receives: Drug: Dexmedetomidine
placebo	Placebo comparator	Normal saline Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Heart Rate (HR)
beats per minute (bpm)
Measured: Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
Systolic Blood Pressure (SBP)
mmHg
Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis.
Measured: Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
Diastolic Blood Pressure (DBP)
mmHg
Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis.
Measured: Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).

Secondary outcomes (1)

Incidence of Emergence Agitation (EA)
Using a Pediatric Anesthesia Emergence Delirium (PAED) score, emergence agitation scores will be recorded. The PAED score consists of 5 different criteria which are assessed from 0 to 4 once the patient has woken up. These criteria are then totaled; the total may range from 0 to 20, where 0 represents no emergence agitation and 20 represents maximal agitation. For this study, patients with a maximum PAED score of >10 and >12 were considered to be agitated.
Measured: The highest PAED score for each patient within the first 30 minutes after waking up was recorded.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Aug 2014

First posted8 Feb 2012 (estimated)
Study startJan 2012
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for TonsillectomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 418 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01528891
Sponsor's protocol ID: PRO11070498
Status last verified: Mar 2018
First submitted: 6 Feb 2012
Last updated: 8 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
Tonsillectomy and Adenotonsillectomy in Children
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
Recruiting
Coblator Wand Comparative Analysis
Tonsillectomy, Adenoidectomy
Recruiting
Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy
Tonsillitis

All Tonsillectomy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children
ClinicalTrials.gov ID: NCT01528891
Acronym / sponsor ID: PRO11070498
Conditions: Tonsillectomy
Keywords: tonsillectomy, emergence agitation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 418 participants (actual)
Lead sponsor: Peter DavisUniversity, hospital or other
Collaborators: Hospira, now a wholly owned subsidiary of Pfizer
Study start: Jan 2012
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 8 Feb 2012 (estimated)
Results: Posted 25 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dexmedetomidine	Active comparator	Drug: DexmedetomidineDexmedetomidine
placebo	Placebo comparator	Other: PlaceboNormal saline

Who may qualify

Ages: 4 to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion
ASA 1,2,3
females who have started menses but have a negative urine pregnancy test

Key exclusion criteria (6 listed)

patients with known dysrhythmias,
not recovering in the ICU
developmental delay,
autism communication disorder
bleeding disorder

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexmedetomidineAlso: Precedex0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery	Drug	Dexmedetomidine
Placebo	Other	placebo

Primary outcome

Heart Rate (HR)
Time frame: Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
beats per minute (bpm)
Systolic Blood Pressure (SBP)
Time frame: Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
mmHg Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis.
Diastolic Blood Pressure (DBP)
Time frame: Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
mmHg Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis.

1 secondary outcome

Incidence of Emergence Agitation (EA)
Time frame: The highest PAED score for each patient within the first 30 minutes after waking up was recorded.

Results and safety

Results posted to the registry on 25 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dexmedetomidine	200	200
Placebo	200	200

Primary outcome: Heart Rate (HR)

Time frame: Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).. Mean (Standard Deviation). Unit: bpm

Measure	Dexmedetomidine n = 195	Placebo n = 198
Baseline HR	120 (16)	121 (16)
1 min HR	107 (18)	121 (16)
2 min HR	104 (16)	120 (15)
3 min HR	105 (14)	119 (15)
4 min HR	105 (15)	118 (15)
5 min HR	105 (15)	117 (15)
PACU HR	94 (13)	108 (16)

Dexmedetomidine vs Placebo: p <0.01, t-test, 2 sided
Dexmedetomidine: p <0.01, ANOVA
Placebo: p <0.01, ANOVA

Population analysed: Heart rate values were compared between groups at each time point and within groups over time.

Primary outcome: Systolic Blood Pressure (SBP)

Time frame: Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).. Mean (Standard Deviation). Unit: mmHg

Measure	Dexmedetomidine n = 194	Placebo n = 197
Baseline SBP	99 (16)	99 (16)
1 min SBP	104 (16)	100 (15)
2 min SBP	99 (14)	99 (14)
3 min SBP	95 (13)	98 (14)
4 min SBP	93 (13)	97 (15)
5 min SBP	92 (13)	96 (15)
PACU SBP	97 (12)	105 (17)

Dexmedetomidine vs Placebo: p <0.01, t-test, 2 sided
Dexmedetomidine: p <0.01, ANOVA
Placebo: p <0.01, ANOVA

Population analysed: Systolic blood pressure values were compared between groups at each time point and within groups over time.

Primary outcome: Diastolic Blood Pressure (DBP)

Time frame: Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).. Mean (Standard Deviation). Unit: mmHg

Measure	Dexmedetomidine n = 194	Placebo n = 196
Baseline DBP	47 (9)	47 (9)
1 min DBP	52 (10)	47 (9)
2 min DBP	48 (9)	47 (8)
3 min DBP	45 (8)	46 (8)
4 min DBP	44 (8)	45 (9)
5 min DBP	43 (8)	45 (8)
PACU DBP	50 (7)	55 (11)

Dexmedetomidine vs Placebo: p <0.01, t-test, 2 sided
Dexmedetomidine: p <0.01, ANOVA
Placebo: p <0.01, ANOVA

Population analysed: Diastolic blood pressure values were compared between groups at each time point and within groups over time.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dexmedetomidine	1 of 200 (0.5%)	18 of 200 (9%)	Not reported
Placebo	0 of 200 (0%)	34 of 200 (17%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Tonsillectomy

Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
Tonsillectomy and Adenotonsillectomy in Children
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
Recruiting
Coblator Wand Comparative Analysis
Tonsillectomy, Adenoidectomy
Recruiting
Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy
Tonsillitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter J Davis, MD principal investigator

University of Pittsburgh

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexmedetomidine in people with Tonsillectomy, run by Peter Davis at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Rate (HR) (time frame: Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01528891.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.