Obstructive Sleep Apnea
Conditions
Keywords
obstructive sleep apnea, Tonsillectomy, Tonsillotomy, Inflammation, Pain, Post tonsillectomy bleeding
Brief summary
Tonsil surgery for children suffering from obstructive sleep apnea have significant post operative morbidity including pain and occasionally bleeding. This morbidity is partly caused by post surgical inflammation. This inflammatory process can be quantified using various proinflammatory cytokines. the goal of this study is to objectively compare the inflammatory process after treatment of obstructive sleep apnea with different surgical approaches to the enlarged tonsils.
Detailed description
Tonsil surgery for children suffering from obstructive sleep apnea have significant post operative morbidity including pain and occasionally bleeding. This morbidity is partly caused by post surgical inflammation. This inflammatory process can be quantified using various proinflammatory cytokines. the goal of this study is to objectively compare the inflammatory process after treatment of obstructive sleep apnea with different surgical approaches to the enlarged tonsils. In the study three approaches are prospectively compared: 1. Tonsillectomy - using electrocautery resecting all tonsillar tissue. 2. Debrider Tonsillotomy - reducing the tonsillar tissue with a debrider. 3. laser Tonsillotomy - reducing tonsillar tissue using a CO2 laser. All patients will be randomized to one of three arms. Each arm will include 25 children. All children will have a preoperative and postoperative sleep study. Questioners assessing pain, amount of medication used to control pain and sleep disturbance during the first 7 days after surgery will be filled by the child caretaker. Blood will be drawn immediately before surgery and 18-24 hours after surgery. The following blood products will be assessed: White blood cells, clotting factors, C reactive protein, IL1 beta,TNF alpha, IL6, IL2. If the study will show objectively and subjectively that partial resection of the tonsil compared to complete tonsillectomy is less painful and has less postoperative inflammation.
Interventions
PROCEDURETonsillectomy, laser tonsillotomy, debrider tonsillotomy
Each arm will be treated by one of the three methods in addition to adenoidectomy
Sponsors
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
age 2-16 obstructive sleep apnea AHI\>5 Hypertrophy of tonsils and adenoids \-
Exclusion criteria
Children with recurrent tonsillitis craniofacial anomalies Neuromuscular disease Down syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Difference between the three arms regarding pain, post tonsillectomy bleeding and post operative sleep disturbance. | 12 months |
Countries
Israel
Outcome results
None listed