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NCT Number: NCT07656831

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

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.

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Key information

Conditions

Chronic Tonsillitis

Age range

5 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allama Iqbal Teaching Hospital

Dera Ghazi Khan, Punjab Province, 32200, Pakistan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Cold Steel Dissection Tonsillectomy

Procedure

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 Tonsillectomy

Procedure

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.

Primary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Allama Iqbal Teaching Hospital

Other Gov

Registry information

Official study title

Comparison of Harmonic Scalpel Versus Cold Steel Dissection Tonsillectomy in Children

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

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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