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

NCT ID: NCT07035314

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-08
• Study Completion Date: 2025-08-01

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.

Conditions

Tonsillitis Chronic; Tonsillitis Recurrent; OSA - Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: PROCEDURE

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

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

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

Group Type: EXPERIMENTAL

NSAIDs

Intervention Type: DRUG

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

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

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

Group Type: ACTIVE_COMPARATOR

Control (Standard treatment)

Intervention Type: DRUG

3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department.

Interventions

Dexamethasone

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

Intervention Type: PROCEDURE

NSAIDs

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

Intervention Type: DRUG

Control (Standard treatment)

3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department.

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ainshams university hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Abdurrahman samir mohamed Mr, MBBS

Role: CONTACT

samirabdelrahman114@gmail.com

01069466215 ext. +20

Facility Contacts

Abdurrahman samir mohamrd Mr, MBBS

Role: primary

samirabdelrahman114@gmail.com

01069466215 ext. +20

References

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.

Reference Type: BACKGROUND

PMID: 24012792 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

FMASU MS 41/2025

Identifier Type: -

Identifier Source: org_study_id