About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: Between 4-10 years.
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Dexamethasone
Procedure/Surgery1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and paracetamol.
NSAIDs
Drug2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.
Control (Standard treatment)
Drug3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department.
Treatment groups
Trial outcomes
Primary outcomes
post tonsillectomy pain
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 outcomes
Additional pain medication needed
The percentage of the patients in group 1 and 2 that will need extra analgesia
Pt feedback after tonsillectomy
Patient satisfaction and return to normal activity.
Complications
Adverse effects noticed such as nausea, vomiting, infection and post tonsillectomy bleeding.
Sponsors and contacts
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