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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02162433
Other study ID # 14-019H
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date March 2015
Est. completion date April 23, 2018

Study information

Verified date April 2020
Source Massachusetts Eye and Ear Infirmary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators aim to investigate the effect of dexmedetomidine on the perioperative respiratory complications in this patient population undergoing both awake and deep tracheal extubation.


Description:

We propose a prospective double-blinded randomized controlled trial. 336 pediatric patients presenting to Massachusetts Eye and Ear Infirmary (MEEI) for adenotonsillectomy who are eligible for the study based on inclusion and exclusion criteria will be recruited. A Clinical Pharmacy specialist, will be in charge of preparing the dexmedetomidine and placebo doses and will randomize the patients to four equally numbered groups. The anesthesiologist will receive the assignment for the extubation method in a sealed envelope from the Clinical Pharmacy specialist. Multiple parameters will be recorded in perioperative period to quantify perioperative adverse respiratory events.


Recruitment information / eligibility

Status Terminated
Enrollment 92
Est. completion date April 23, 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender All
Age group 3 Years to 16 Years
Eligibility Inclusion Criteria:

- Patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without myringotomy or myringoplasty

- ASA 1 & 2

Exclusion Criteria:

- Known allergy or hypersensitivity reaction to dexmedetomidine

- Organ dysfunction (renal/hepatic failure or leukemia)

- Cardiac disease (congenital or acquired)

- Airway or thoracic malformation

- Cerebral palsy

- Hypotonia

- Need for premedication

- Current/recent upper respiratory infection (within four weeks prior to the surgery)

- Asthma

- Allergy or intolerance to clonidine

- Non-English speaking parents/patients.

Study Design


Intervention

Drug:
Normal Saline
to arms 2,4. Serves as the placebo.
Dexmedetomidine
to arms 1,3

Locations

Country Name City State
United States MEEI Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Respiratory Complications Number of patients exhibiting any of the following outcomes:
desaturation to less than 95% for more than 10 seconds;
breath holding;
complete or partial laryngospasm;
bronchospasm;
croup;
number of episodes of persistent cough (three or more consecutive coughs);
negative pressure pulmonary edema;
stridor.
24 hours
Secondary Number of Participants With Emergence Agitation Number of patients with an incidence of emergence agitation post-surgery defined by the Pediatric Anesthesia Emergence Delirium (PAED) scale of >10.
Emergence agitation is characterized by non-purposeful movement, restlessness, thrashing, incoherence, inconsolability, and unresponsiveness. The PAED is a scale used to assess emergence agitation in our patient population. It's minimum value is zero and maximum value is 20, with 0 being no emergence agitation and 20 being the most agitated state.
24 hours
Secondary Number of Participants With Postoperative Nausea and Vomiting (PONV) Number of patients who experienced postoperative nausea and vomiting (PONV) as noted by the parental questionnaire administered 24 hours after the patient is discharged. 24 hrs
Secondary Average Time From End of Surgery to Leaving the Operating Room 24 hours
Secondary The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission) 24 hrs
Secondary Number of Participants Needing Follow-up Pain Medication 24-hour postoperative pain medication requirement assessed by a parental questionnaire administered 24 hours after discharge. The parents are asked whether their child took any pain medication within the last 24 hours since the surgery. 24 hours
Secondary Number of Patients With Unplanned Hospital Admission Any unplanned hospital admission due to perioperative respiratory adverse events. 24 hours
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