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Risk Stratification of Post Tonsillectomy Respiratory Complications in the Pediatric Population

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Information provided by:
Hadassah Medical Organization Identifier:
First received: December 8, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted

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.


Pre-operative, operative and immediate post-operative parameters could predict post tonsillectomy respiratory complications.

Post Tonsillectomy Respiratory Complications

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • respiratory distress

Estimated Enrollment: 200
post tonsillectomy


Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
children, suffering of obstructive sleep apnea, having their tonsills removed

Inclusion Criteria:

  1. Pediatric patient < 14 years old
  2. Obstructive sleep apnea according to polysomnography
  3. Surgery: Tonsillectomy/Tonsillotomy

Exclusion Criteria:

1. Patient suffering from known respiratory disease

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01257321

Contact: Nir Hirshoren, MD 0097226776476
Contact: Hadas Lemberg, PhD 00972267777572

Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    0097226776095   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information Identifier: NCT01257321     History of Changes
Other Study ID Numbers: OSA-HMO-CTIL
Study First Received: December 8, 2010
Last Updated: December 8, 2010 processed this record on August 16, 2017