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

Ain Shams University

Status: Enrolling

Conditions: OSA - Obstructive Sleep Apnea; Tonsillitis Recurrent; Tonsillitis Chronic

Treatments: Drug: Control (Standard treatment); Procedure: Dexamethasone; Drug: NSAIDs

Study type: Interventional

Funder types: Other

Identifiers

NCT07035314

FMASU MS 41/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par

Experimental group

Description:

1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par

Treatment:

Procedure: Dexamethasone

2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and ant

Experimental group

Description:

2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.

Treatment:

Drug: NSAIDs

3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill

Active Comparator group

Description:

3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill

Treatment:

Drug: Control (Standard treatment)