NCT00697788 is a Phase 2 clinical trial of Dexmedetomidine in Burns, sponsored by Massachusetts General Hospital.

Who is sponsoring NCT00697788?

NCT00697788 is sponsored by Massachusetts General Hospital.

What drugs are being tested in NCT00697788?

Interventions in NCT00697788: Dexmedetomidine.

What condition does NCT00697788 study?

NCT00697788 studies Burns, Sedation.

Is NCT00697788 still recruiting?

NCT00697788 is currently completed. Last updated 17 July 2017.

Are results published for NCT00697788?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-07-17 · How we verify

NCT00697788

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

Completed Phase 2 Results posted Last updated 17 July 2017

What this trial tests

Phase 2 trial testing Dexmedetomidine in Burns in 8 participants. Completed in 30 December 2008.

Timeline

16 July 2007

Primary endpoint
30 December 2008

30 December 2008

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	16 July 2007
Primary completion	30 December 2008
Estimated completion	30 December 2008
Sites	1 location across United States

Drugs / interventions tested

Dexmedetomidine (dexmedetomidine) — full drug profile →

Conditions studied

Burns — all drugs for Burns →
Sedation — all drugs for Sedation →

Sponsor

Massachusetts General Hospital

Who can join

Adults 2 to 18, any sex, with Burns or Sedation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change in Mean Arterial Pressure (MAP) Primary · 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure.

Group	Value	95% CI
Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV	26.7	± 7.5
Cohort 2: Dexmedetomidine Bolus + 0.7 mcg/kg/hr Infusion	30.8	± 10.2
Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion	26.5	± 10.5
Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr	24.5	± 13.8
Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion	25.5	± 12.5
Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr	18	± 8.7
Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr	15	± 7
Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr	15.6	± 8.0

Presence of Arrhythmias. Secondary · 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

Presence of arrhythmias was studied using a 3 lead realtime EKG throughout study.

Group	Value	95% CI
Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV	0
Cohort 2: Dexmedetomidine Bolus + 0.7 mcg/kg/hr Infusion	0
Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion	0
Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr	0
Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion	0
Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr	0
Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr	0
Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr	0

Oxygen Saturation Secondary · 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

Pulse oximetry was used to measure oxygen saturation.

Group	Value	95% CI
Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV	99.8	± 0.5
Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion	99.5	± 0.8
Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion	99.5	± 0.8
Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr	98.6	± 1.1
Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion	98.6	± 1.1
Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr	98.6	± 1.3
Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr	99.3	± 1.5
Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr	99.5	± 0.6

Heart Rate Secondary · 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

Heart Rate recorded off EKG in beats per minute

Group	Value	95% CI
Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV	125.6	± 16.6
Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion	122	± 15.8
Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion	127.5	± 11.9
Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr	125.5	± 17.2
Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion	122.8	± 17.8
Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr	129.7	± 11.6
Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr	132.3	± 17.9
Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr	125	± 8.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Data was collected for the two hour period of the study.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV

Serious: 0/8 (0%)

Deaths: 0/8

Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion

Serious: 0/7 (0%)

Deaths: 0/7

Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion

Serious: 0/4 (0%)

Deaths: 0/4

Cohort 4: Dexmedetomidine 1.3 mcg/kg/hr Infusion

Serious: 0/4 (0%)

Deaths: 0/4

Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion

Serious: 0/4 (0%)

Deaths: 0/4

Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr Infusion

Serious: 0/3 (0%)

Deaths: 0/3

Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr Infusion

Serious: 0/3 (0%)

Deaths: 0/3

Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr Infusion

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (1 terms — click to expand)

Reaction	System	Cohort 1: Dexmedetomidine …	Cohort 2: Dexmedetomidine …	Cohort 3: Dexmedetomidine …	Cohort 4: Dexmedetomidine …	Cohort 5: Dexmedetomidine …	Cohort 6: Dexmedetomidine …	Cohort 7: Dexmedetomidine …	Cohort 8: Dexmedetomidine …
Significant hypotension defined as mean arterial pressure <50 mm Hg	Vascular disorders	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT00697788 adverse events section.

Sponsor's own description

Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Dexmedetomidine

Trials testing the same drug.

NCT06824077 — Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle · EARLY_PHASE1 · not yet recruiting
NCT07398066 — DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial) · NA · not yet recruiting
NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
NCT07306702 — Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients · Phase 4 · withdrawn
NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting

Other recruiting trials for Burns

Currently open trials in the same condition.

NCT07259668 — Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns · recruiting
NCT07248930 — Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Thermal Burns · recruiting
NCT07313735 — The Effect of Cartoon Character-Printed Band Use During Burn Dressing on Fear, Stress, Pain, and Physiological Parameter · NA · recruiting
NCT07142824 — Comparison Between Burn Dressing Using Tilapia-Fish Skin Versus Regular Dressing · NA · recruiting
NCT07277166 — The Effect of Mobile Robot Assisted Gait Training on Gait Performance in Chronic Patients With Impaired Gait Function Af · NA · recruiting

Other Massachusetts General Hospital trials

Trials by the same sponsor.

NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00697788 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 17 July 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00697788.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00697788

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Dexmedetomidine

Other recruiting trials for Burns

Other Massachusetts General Hospital trials

Verify against primary sources