Chronic TonsillitisNCT07656831
Study Comparing Harmonic Scalpel and Conventional Cold Steel Tonsil Removal Surgery in Children Requiring Tonsillectomy
A study testing Cold Steel Dissection Tonsillectomy and Harmonic Scalpel Tonsillectomy in people with Chronic Tonsillitis, run by Allama Iqbal Teaching Hospital at 1 site in Pakistan.
Trial summary
This clinical trial aims to compare two commonly used methods of tonsil removal surgery (tonsillectomy) in children and adults with chronic tonsillitis. Chronic tonsillitis refers to repeated episodes of tonsil infection that occur frequently over several years and require surgical removal of the tonsils. Read more about this study
- Who is it for?
- Ages 5 to 45 years
- Conditions the study is for
- Chronic Tonsillitis
- What is being tested?
- Cold Steel Dissection Tonsillectomy and Harmonic Scalpel Tonsillectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- chronic tonsillitis and planned for tonsillectomy
Who cannot join
- Upper respiratory tract infection within preceding three weeks
- Peritonsillar abscess or history of quinsy
- Known bleeding disorder (hemophilia, thrombocytopenia) or on anticoagulant therapy
- Craniofacial anomalies or syndromic conditions affecting airway or surgical anatomy
- Uncontrolled diabetes, severe cardiopulmonary disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Allama Iqbal Teaching Hospital
Dera Ghazi Khan, Punjab Province, 32200
About this study
Official title: Comparison of Harmonic Scalpel Versus Cold Steel Dissection Tonsillectomy in Children
This clinical trial aims to compare two commonly used methods of tonsil removal surgery (tonsillectomy) in children and adults with chronic tonsillitis. Chronic tonsillitis refers to repeated episodes of tonsil infection that occur frequently over several years and require surgical removal of the tonsils.
The main question this study aims to answer is:
Read more
Does tonsillectomy performed with a harmonic scalpel result in less pain three days after surgery compared with the conventional cold steel dissection technique?
Researchers will also compare:
How long the surgery takes to perform How much blood is lost during the operation The level of pain experienced three days after surgery
A total of 66 participants aged 5 to 45 years who are scheduled for tonsillectomy because of chronic tonsillitis will take part in the study. Participants will be randomly assigned to undergo either conventional cold steel dissection tonsillectomy or harmonic scalpel tonsillectomy.
All surgeries will be performed by experienced ENT surgeons following standard hospital procedures. After surgery, participants will receive routine medications and instructions for home care. They will be followed for three days and then return to the ENT clinic for assessment of pain and examination of the healing of the surgical site.
The study hypothesis is that patients undergoing harmonic scalpel tonsillectomy will experience less pain three days after surgery than those undergoing conventional cold steel dissection tonsillectomy.
- Conditions
- Chronic Tonsillitis
- Being tested
- Cold Steel Dissection Tonsillectomy, Harmonic Scalpel Tonsillectomy
- Keywords
- Tonillectomy, Harmonic Scalpel, Cold Steel Dissection, Postoperative Pian, Intraoperative Blood Loss, Operative time, Chronic Recurrent Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Steel Dissection TonsillectomyProcedure or surgery
The tonsils will be removed using cold steel instruments, and hemostasis will be achieved by bipolar diathermy or ligatures according to institutional protocol.
Harmonic Scalpel TonsillectomyProcedure or surgery
A harmonic scalpel with a curved blade (Ethicon Endosurgery, Johnson \& Johnson, USA) will be used for dissection and hemostasis (using ultrasonic energy) during tonsil removal.
| Study group | Role | What they receive |
|---|---|---|
| Cold Steel Dissection Tonsillectomy | Active comparator | Participants randomized to this arm will undergo conventional cold steel dissection tonsillectomy. Receives: Procedure: Cold Steel Dissection Tonsillectomy |
| Harmonic Scalpel Tonsillectomy | Experimental | Participants randomized to this arm will undergo extracapsular tonsillectomy using a harmonic scalpel Receives: Procedure: Harmonic Scalpel Tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score
Postoperative pain will be assessed three days after tonsillectomy using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst tolerable pain. Mean VAS scores will be compared between the harmonic scalpel and cold steel dissection groups.
Measured: From surgery (day of tonsillectomy) to three (03) days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Oct 2025
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic TonsillitisStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shoaib Ahmad Zia, Allama Iqbal Teaching Hospital
- Investigators
- Sharbaz H Khosa, FCPS, Study chair, Allama Iqbal Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656831
- Sponsor's protocol ID
- U1111-1342-4276
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Harmonic Scalpel Versus Cold Steel Dissection Tonsillectomy in Children
- ClinicalTrials.gov ID
- NCT07656831
- Acronym / sponsor ID
- U1111-1342-4276
- Conditions
- Chronic Tonsillitis
- Keywords
- Tonillectomy, Harmonic Scalpel, Cold Steel Dissection, Postoperative Pian, Intraoperative Blood Loss, Operative time, Chronic Recurrent Tonsillitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Allama Iqbal Teaching HospitalOther government
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 18 Jun 2026 (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.
This clinical trial aims to compare two commonly used methods of tonsil removal surgery (tonsillectomy) in children and adults with chronic tonsillitis. Chronic tonsillitis refers to repeated episodes of tonsil infection that occur frequently over several years and require surgical removal of the tonsils.
The main question this study aims to answer is:
Does tonsillectomy performed with a harmonic scalpel result in less pain three days after surgery compared with the conventional cold steel dissection technique?
Researchers will also compare:
How long the surgery takes to perform How much blood is lost during the operation The level of pain experienced three days after surgery
A total of 66 participants aged 5 to 45 years who are scheduled for tonsillectomy because of chronic tonsillitis will take part in the study. Participants will be randomly assigned to undergo either conventional cold steel dissection tonsillectomy or harmonic scalpel tonsillectomy.
All surgeries will be performed by experienced ENT surgeons following standard hospital procedures. After surgery, participants will receive routine medications and instructions for home care. They will be followed for three days and then return to the ENT clinic for assessment of pain and examination of the healing of the surgical site.
The study hypothesis is that patients undergoing harmonic scalpel tonsillectomy will experience less pain three days after surgery than those undergoing conventional cold steel dissection tonsillectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold Steel Dissection Tonsillectomy | Active comparator | Procedure: Cold Steel Dissection TonsillectomyParticipants randomized to this arm will undergo conventional cold steel dissection tonsillectomy. |
| Harmonic Scalpel Tonsillectomy | Experimental | Procedure: Harmonic Scalpel TonsillectomyParticipants randomized to this arm will undergo extracapsular tonsillectomy using a harmonic scalpel |
Who may qualify
- Ages
- 5 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- chronic tonsillitis and planned for tonsillectomy
Key exclusion criteria (5 listed)
- Upper respiratory tract infection within preceding three weeks
- Peritonsillar abscess or history of quinsy
- Known bleeding disorder (hemophilia, thrombocytopenia) or on anticoagulant therapy
- Craniofacial anomalies or syndromic conditions affecting airway or surgical anatomy
- Uncontrolled diabetes, severe cardiopulmonary disease
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 |
|---|---|---|
| Cold Steel Dissection TonsillectomyThe tonsils will be removed using cold steel instruments, and hemostasis will be achieved by bipolar diathermy or ligatures according to institutional protocol. | Procedure or surgery | Cold Steel Dissection Tonsillectomy |
| Harmonic Scalpel TonsillectomyA harmonic scalpel with a curved blade (Ethicon Endosurgery, Johnson \& Johnson, USA) will be used for dissection and hemostasis (using ultrasonic energy) during tonsil removal. | Procedure or surgery | Harmonic Scalpel Tonsillectomy |
Primary outcome
Postoperative Pain Score
Time frame: From surgery (day of tonsillectomy) to three (03) days postoperatively
Postoperative pain will be assessed three days after tonsillectomy using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst tolerable pain. Mean VAS scores will be compared between the harmonic scalpel and cold steel dissection groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Tonsillitis
Not yet recruiting
Recovery From Tonsil Surgery.
Recurrent Tonsillitis, Chronic Tonsillitis
Active, not recruitingObservational study
A Comparative Study of Monopolar Versus Bipolar Electrocautery Post Tonsillectomy Outcomes.
Chronic Tonsillitis
Active, not recruiting
Intracapsular Tonsillectomy in Adults
Tonsil Disease, Tonsillitis
Recruiting
The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.
Tonsillitis Chronic, Tonsillitis Recurrent
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. This study is not recruiting at the moment.
Sharbaz H Khosa, FCPS study chair
Allama Iqbal Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Steel Dissection Tonsillectomy and Harmonic Scalpel Tonsillectomy in people with Chronic Tonsillitis, run by Allama Iqbal Teaching Hospital at 1 site in Pakistan.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 18 Jun 2026. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (time frame: From surgery (day of tonsillectomy) to three (03) days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2026.