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NCT01462539 Clinical Trial

Adenotonsillectomy and Obstructive Sleep Apnea Study

Adenotonsillectomy Clinical Trial

Official title:
Factors That Increase Length of Stay After Outpatient Surgery of 3-6 Year Olds With OSAS Symptoms Versus Without OSAS Symptoms After Adenotonsillectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01462539
Other study ID # IRB11-00364
Secondary ID
Status Completed
Phase N/A
First received October 27, 2011
Last updated November 29, 2012
Start date October 2011
Est. completion date October 2012

Study information
Verified date November 2012
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Adenotonsillectomies are one of the most common childhood surgeries and are first-line treatment to correct childhood obstructive sleep apnea syndrome (OSAS). This is a study comparing patients with and without OSA looking at the length of stay following adenotonsillectomy and the factors affecting length of stay.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date October 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 6 Years
Eligibility Inclusion Criteria:

1. history of snoring/gasping/ or pause in breathing reported by caregivers.

2. age 3-6 years old

3. undergoing adenotonsillectomy only no concurrent surgery

4. scheduled as outpatient and plan for discharge home

Exclusion Criteria:

1. Preoperatively requiring additional respiratory support

2. scheduled for concurrent surgery that could increase total general anesthetic time

3. recurrent adenotonsillitis as sole indication for surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Length of stay (LOS) 1 Day (Day of Surgery) No
Secondary Cause of increased Length of stay (LOS) 1 Day (Day of Surgery) No
See also
  Status Clinical Trial Phase
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Terminated NCT03618823 - Non-opioids for Analgesia After Adenotonsillectomy in Children Phase 1/Phase 2
Completed NCT01096797 - Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children Phase 4
Completed NCT04527393 - Individualized Analgesia for Pediatric Adenotonsillectomy Phase 4
Completed NCT02384187 - Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients Phase 3
Completed NCT01285804 - Impact of Using a Cuffed Endotracheal Tube on Limiting the Risk of Airway Fire N/A
Recruiting NCT05639777 - Intranasal Dexmedetomidine in Children Undergoing Adenotonsillectomy Suffering From Mild Upper Respiratory Tract Infection Phase 4
Completed NCT02501122 - Retrospective Analysis in Quality of Care Measures in Pediatric Adenotonsillectomy Patients N/A
Completed NCT03378830 - Pain at Home After Tonsillectomy With or Without Adenoidectomy
Recruiting NCT05051189 - Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea Early Phase 1
Terminated NCT04879823 - Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity Phase 3
Completed NCT01917097 - Bradycardia Following Intraoperative Administration of Dexmedetomidine N/A
Completed NCT00849966 - Celecoxib for Pediatric Adenotonsillectomy Phase 2
Completed NCT06356298 - Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy Phase 2
Completed NCT05364281 - The Changes of ETT Cuff Pressures After Head and Neck Positions Placed for Adenotonsillectomy and Tonsillectomy in Children
Completed NCT03551067 - Oral Dexmedetomidine for Parental Separation in Pediatrics Undergoing Adenotonsillectomy Phase 4
Terminated NCT04791761 - Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy Phase 1/Phase 2