Study Comparing Harmonic Scalpel and Conventional Cold Steel Tonsil Removal Surgery in Children Requiring Tonsillectomy

June 15, 2026 updated by: Shoaib Ahmad Zia, Allama Iqbal Teaching Hospital

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:

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Dera Ghazi Khan, Punjab Province, Pakistan, 32200
        • Allama Iqbal Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • chronic tonsillitis and planned for tonsillectomy

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cold Steel Dissection Tonsillectomy
Participants randomized to this arm will undergo conventional cold steel dissection tonsillectomy.
Procedure: Cold Steel Dissection Tonsillectomy
The tonsils will be removed using cold steel instruments, and hemostasis will be achieved by bipolar diathermy or ligatures according to institutional protocol.
Experimental: Harmonic Scalpel Tonsillectomy
Participants randomized to this arm will undergo extracapsular tonsillectomy using a harmonic scalpel
Procedure: Harmonic Scalpel Tonsillectomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From surgery (day of tonsillectomy) to three (03) days postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative Time
Time Frame: During the surgical procedure (from insertion of mouth gag to removal after hemostasis).
Duration of surgery measured in minutes from the start of tonsil dissection to completion of surgery and achievement of hemostasis.
During the surgical procedure (from insertion of mouth gag to removal after hemostasis).
Intraoperative Blood Loss
Time Frame: During the surgical procedure (from start of dissection to completion of hemostasis).
Blood loss measured in milliliters using suction canister and pre-weighed sponges (1 g increase = 1 mL blood).
During the surgical procedure (from start of dissection to completion of hemostasis).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allama Iqbal Teaching Hospital

Investigators

  • Study Chair: Sharbaz H Khosa, FCPS, Allama Iqbal Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Actual)

March 30, 2026

Study Completion (Actual)

March 30, 2026

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • U1111-1342-4276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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