Tonsillitis Chronic, Tonsillitis Recurrent, OSA - Obstructive Sleep Apnea
Conditions
Keywords
tonsillitis, tonsillectomy, post tonsillectomy pain, Dexamethasone infiltration in tonsillar bed, NSAIDs
Brief summary
The aim of this study is to compare the efficacy of adding paracetamol to systemic non-steroidal anti-inflammatory drugs (NSAIDs) versus adding dexamethasone as local infiltration to paracetamol on post tonsillectomy pain control.
Detailed description
A Prospective Randomized Controlled study. The study will be conducted at Ain Shams University hospital, Otolaryngology Department. Study period is 6 months from approval of the protocol. Study Participants will be recruited from outpatient ENT clinic, and ENT department inpatients.
Interventions
PROCEDUREDexamethasone
1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and paracetamol.
DRUGNSAIDs
2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.
DRUGControl (Standard treatment)
3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
3 groups
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Age: Between 4-10 years. * Indications of tonsillectomy such as: * Recurrent acute attacks at least 7 episodes in the past year or at least 5 episodes per year for 2 years or at least 3 episodes per year for 3 years. * Chronic tonsillitis and hypertrophy of tonsils causing sleep apnea, difficulty in deglutition, interference in speech. * Tonsillectomy by cold dissection only. * American Society of Anesthesiologists (ASA) classification 1,2 (Normal Health, Mild systematic disease).
Exclusion criteria
* Patients with age less than 4 and more than 10 years. * Indications of tonsillectomy other than chronic tonsillitis such as lymphoma. * Patients on chronic steroid therapy * Hemoglobin level less than 10 gm/dL * Presence of acute infection in the upper respiratory tract, acute tonsillitis * American Society of Anesthesiologists (ASA) classification ASA 3,4 (Severe systematic disease such as uncontrolled Diabetes, cardiac disease, liver or kidney disease, life threating medical conditions) * Regular use of analgesics within a week of surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post tonsillectomy pain | DAY 0 6h, 24h post-operatively and DAY 5 post-operatively | The primary endpoints that will be used is resting pain scores using virtual analogue scale; VAS score (0: no pain-10: worst pain) at DAY 0 after 6h, 24h and DAY 5 post-operatively. Where pain score will be measured at multiple points during the outcome intervals, the pain scores at the time closest to six and 24h will be used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional pain medication needed | 2 weeks post operatively | The percentage of the patients in group 1 and 2 that will need extra analgesia |
| Pt feedback after tonsillectomy | 2 weeks post operatively | Patient satisfaction and return to normal activity. |
| Complications | 2 weeks post operatively | Adverse effects noticed such as nausea, vomiting, infection and post tonsillectomy bleeding. |
Countries
Egypt
Contacts
Primary ContactAbdurrahman samir mohamed Mr, MBBS
Outcome results
None listed