- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01257321
Risk Stratification of Post Tonsillectomy Respiratory Complications in the Pediatric Population
Obstructive sleep apnea syndrome (OSAS) is the most common indication for tonsillectomy and adenoidectomy in young children. According to previous studies, as much as 8 to 20% of patients will develop post operative respiratory complications requiring medical intervention. The pre-operative risk factors that could predict respiratory complications retrospectively analyzed were young age, obesity and high preoperative apnea-hypopnea index. Despite the removal of obstructing lymphoid tissue, upper airway obstruction occurs on the first postoperative night in children with OSA. There is a debate regarding the post-operative duration and monitoring needed in children with OSA.
Hypothesis:
Pre-operative, operative and immediate post-operative parameters could predict post tonsillectomy respiratory complications.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Jerusalem, Israel
- Hadassah Medical Organization
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pediatric patient < 14 years old
- Obstructive sleep apnea according to polysomnography
- Surgery: Tonsillectomy/Tonsillotomy
Exclusion Criteria:
1. Patient suffering from known respiratory disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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post tonsillectomy
children
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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respiratory distress
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Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OSA-HMO-CTIL
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Clinical Trials on Post Tonsillectomy Respiratory Complications
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Boston Children's HospitalTerminatedPost-tonsillectomy Pain | Post-tonsillectomy Activity | Post-tonsillectomy HydrationUnited States
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Brooke Army Medical Center59th Medical Wing; Madigan Army Medical Center; Tripler Army Medical Center; Blanchfield...UnknownSecondary Post Tonsillectomy Hemorrhage | Primary Post Tonsillectomy HemorrhageUnited States
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Ziv HospitalCompletedAcupuncture | Tonsillectomy | Post-Operative PainIsrael
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Minia UniversityCompletedPost Tonsillectomy PainEgypt
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Hillel Yaffe Medical CenterUnknownPost - Tonsillectomy Pain
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Nationwide Children's HospitalNational Institute of General Medical Sciences (NIGMS)CompletedPediatric Post-tonsillectomy PainUnited States
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Assiut UniversityNot yet recruitingIPRF Post Tonsillectomy
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University of TurkuUnknownPost Tonsillectomy PainFinland
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University of Colorado, DenverCompletedPost Operative Pain Management in Children With Tonsillectomy/AdenoidectomyUnited States