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NCT Number: NCT07035314

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

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.

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Key information

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ainshams university hospitals

Cairo, Egypt

Location status: Recruiting

Location contact

Abdurrahman samir mohamrd Mr, MBBS

CONTACT

[email protected]

01069466215 ext. +20

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Procedure

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

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

NSAIDs

Drug

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

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

Control (Standard treatment)

Drug

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

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

Primary outcomes

  1. post tonsillectomy pain

    Time frame: 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

  1. Additional pain medication needed

    Time frame: 2 weeks post operatively

    The percentage of the patients in group 1 and 2 that will need extra analgesia

  2. Pt feedback after tonsillectomy

    Time frame: 2 weeks post operatively

    Patient satisfaction and return to normal activity.

  3. Complications

    Time frame: 2 weeks post operatively

    Adverse effects noticed such as nausea, vomiting, infection and post tonsillectomy bleeding.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdurrahman samir mohamed Mr, MBBS

CONTACT

[email protected]

01069466215 ext. +20

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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.

Acronym: NSAIDs

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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