The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.

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.

• Dexamethasone (Procedure), also known as 1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and paracetamol.: 1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and paracetamol.
• NSAIDs (Drug), also known as 2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.: 2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.
• Control (Standard treatment) (Drug), also known as 3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department.: 3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department.

Primary outcomes

• 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 outcomes

• 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.

Sex: All, ages: 4 Years to 10 Years

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.

• Verma RR, Sriraman R, Rana SK, Ponnanna NM, Rajendar B, Ghantasala P, Rajendra L, Matur RV, Srinivasan VA. E6 protein of human papillomavirus 16 (HPV16) expressed in Escherichia coli sans a stretch of hydrophobic amino acids, enables purification of GST-DeltaE6 in the soluble form and retains the binding ability to p53. Protein Expr Purif. 2013 Nov;92(1):41-7. doi: 10.1016/j.pep.2013.08.010. Epub 2013 Sep 6. PMID 24012792

• Study Protocol (PDF, 2025-01-19)