Risk Stratification of Post Tonsillectomy Respiratory Complications in the Pediatric Population
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ClinicalTrials.gov Identifier: NCT01257321 |
Recruitment Status
: Unknown
Verified December 2010 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted
: December 9, 2010
Last Update Posted
: December 9, 2010
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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.
Condition or disease |
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Post Tonsillectomy Respiratory Complications |
Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Case-Crossover |
Time Perspective: | Prospective |

Group/Cohort |
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post tonsillectomy
children
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- respiratory distress

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Ages Eligible for Study: | up to 14 Years (Child) |
Sexes Eligible for Study: | All |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257321
Contact: Nir Hirshoren, MD | 0097226776476 | drnir@hadassah.org.il | |
Contact: Hadas Lemberg, PhD | 00972267777572 | lhadas@hadassah.org.il |
Israel | |
Hadassah Medical Organization | Not yet recruiting |
Jerusalem, Israel | |
Contact: Arik Tzukert, DMD 0097226776095 arik@hadassah.org.il |
ClinicalTrials.gov Identifier: | NCT01257321 History of Changes |
Other Study ID Numbers: |
OSA-HMO-CTIL |
First Posted: | December 9, 2010 Key Record Dates |
Last Update Posted: | December 9, 2010 |
Last Verified: | December 2010 |