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

NCT07656831 | Completed

• 1 other identifier: U1111-1342-4276
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Tonsillitis

Keywords

Tonillectomy; Harmonic Scalpel; Cold Steel Dissection; Postoperative Pian; Intraoperative Blood Loss; Operative time; Chronic Recurrent Tonsillitis

Outcome Measures

Primary Outcomes (1)

• 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.

  From surgery (day of tonsillectomy) to three (03) days postoperatively

Other Outcomes (2)

• Operative Time

  During the surgical procedure (from insertion of mouth gag to removal after hemostasis).

• Intraoperative Blood Loss

  During the surgical procedure (from start of dissection to completion of hemostasis).

Study Arms (2)

Cold Steel Dissection Tonsillectomy

ACTIVE COMPARATOR

Participants randomized to this arm will undergo conventional cold steel dissection tonsillectomy.

Procedure: Cold Steel Dissection Tonsillectomy

Harmonic Scalpel Tonsillectomy

EXPERIMENTAL

Participants randomized to this arm will undergo extracapsular tonsillectomy using a harmonic scalpel

Procedure: Harmonic Scalpel Tonsillectomy

Interventions

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.

Cold Steel Dissection Tonsillectomy

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.

Harmonic Scalpel Tonsillectomy

Eligibility Criteria

• Age: 5 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• chronic tonsillitis and planned for tonsillectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Allama Iqbal Teaching Hospital: lead

Study Sites (1)

Allama Iqbal Teaching Hospital

Dera Ghazi Khan, Punjab Province, 32200, Pakistan

Location

Study Officials

• Sharbaz H Khosa, FCPS

  Allama Iqbal Teaching Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: October 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)