The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexamethasone, NSAIDs, Control (Standard treatment).
- Who it may be relevant to
- Registry conditions: Tonsillitis Chronic, Tonsillitis Recurrent, OSA - Obstructive Sleep Apnea. Basic parameters: 4 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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.
Interventions
- Procedure Dexamethasone
1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and paracetamol. - Drug NSAIDs
2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol. - Drug Control (Standard treatment)
3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department.
Primary outcome measures
- post tonsillectomy pain [Time frame: DAY 0 6h, 24h post-operatively and DAY 5 post-operatively]
Secondary outcome measures (3)
- Additional pain medication needed [Time frame: 2 weeks post operatively]
- Pt feedback after tonsillectomy [Time frame: 2 weeks post operatively]
- Complications [Time frame: 2 weeks post operatively]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Ainshams university hospitals — Cairo
Publications
- 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 PMID 24012792
Identifiers
NCT: NCT07035314 · FMASU MS 41/2025