Tonsillitis ChronicNSAIDsNCT07035314
The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.
A study testing Dexamethasone and NSAIDs in people with Tonsillitis Chronic and Tonsillitis Recurrent, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Tonsillitis Chronic, Tonsillitis Recurrent, OSA - Obstructive Sleep Apnea
- What is being tested?
- Dexamethasone and NSAIDs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Mar 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ainshams university hospitals
Cairo
Abdurrahman samir mohamrd Mr, MBBS, 01069466215 ext. +20, samirabdelrahman114@gmail.com
About this study
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.
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.
Read the 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.
- Being tested
- Dexamethasone, NSAIDs, Control (Standard treatment)
- Keywords
- tonsillitis, tonsillectomy, post tonsillectomy pain, Dexamethasone infiltration in tonsillar bed, NSAIDs
- Medical subject headings
- Sleep Apnea, Obstructive, Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneProcedure or surgery
Also called 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.
NSAIDsDrug
Also called 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 called 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.
| Study group | Role | What they receive |
|---|---|---|
| 1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par | Experimental | 1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par Receives: Procedure: Dexamethasone |
| 2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and ant | Experimental | 2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol. Receives: Drug: NSAIDs |
| 3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill | Active comparator | 3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill Receives: Drug: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
post tonsillectomy pain
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.
Measured: DAY 0 6h, 24h post-operatively and DAY 5 post-operatively
Secondary outcomes (3)
Additional pain medication needed
The percentage of the patients in group 1 and 2 that will need extra analgesia
Measured: 2 weeks post operatively
Pt feedback after tonsillectomy
Patient satisfaction and return to normal activity.
Measured: 2 weeks post operatively
Complications
Adverse effects noticed such as nausea, vomiting, infection and post tonsillectomy bleeding.
Measured: 2 weeks post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start8 Mar 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tonsillitis ChronicStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035314
- Sponsor's protocol ID
- FMASU MS 41/2025
- Acronym
- NSAIDs
- Status last verified
- May 2025
- First submitted
- 4 Apr 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 2013 Sep 6.
PubMed 24012792
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07035314
- Acronym / sponsor ID
- NSAIDs / FMASU MS 41/2025
- Keywords
- tonsillitis, tonsillectomy, post tonsillectomy pain, Dexamethasone infiltration in tonsillar bed, NSAIDs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 8 Mar 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 3 groups
| Arm | Type | Receives |
|---|---|---|
| 1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par | Experimental | Procedure: Dexamethasone1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par |
| 2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and ant | Experimental | Drug: NSAIDs2- 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 | Active comparator | Drug: Control (Standard treatment)3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age: Between 4-10 years.
- Indications of tonsillectomy such as:
- Tonsillectomy by cold dissection only.
- American Society of Anesthesiologists (ASA) classification 1,2 (Normal Health, Mild systematic disease).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: 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. | Procedure or surgery | 1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par |
| NSAIDsAlso: 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. | Drug | 2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and ant |
| Control (Standard treatment)Also: 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. | Drug | 3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Background: PubMed 24012792Verma 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and NSAIDs in people with Tonsillitis Chronic and Tonsillitis Recurrent, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdurrahman samir mohamed Mr, MBBS (01069466215 ext. +20, samirabdelrahman114@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post tonsillectomy pain (time frame: DAY 0 6h, 24h post-operatively and DAY 5 post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07035314, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.