CompletedNot Applicable

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

Pakistan66 participantsStarted 2025-10-01

Plain-language 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.

Who can participate

Age range

5 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared the harmonic scalpel to traditional cold steel surgery for tonsil removal in children with chronic tonsillitis — based on what this study found about postoperative pain scores, which technique might be better suited for my child's situation?
2Since this trial has already been completed, has my doctor seen or reviewed the results, and do those findings change the recommendation for how my child's tonsillectomy should be performed?
3Pain after tonsillectomy can be really hard on kids — what did this study reveal about how much the harmonic scalpel actually reduces pain compared to the conventional approach, and is the difference meaningful enough to matter day-to-day at home?
4Are there any risks or tradeoffs with the harmonic scalpel technique — like bleeding, healing time, or cost — that this trial may have uncovered, and how do those factor into the decision for my child?
5If the harmonic scalpel approach showed better pain outcomes in this trial, is that technique readily available at the facility where my child would have surgery, or would we need to go somewhere else to access it?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative Pain Score

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

Trial details

NCT IDNCT07656831

SponsorAllama Iqbal Teaching Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-03-30

View on ClinicalTrials.gov More Chronic Tonsillitis trials