Comparing Two Agents Used to Stop Bleeding During Tonsil Removal Surgery: Adrenaline Versus Hydrogen Peroxide

NCT07675278 | Completed

• 1 other identifier: 4824/RTH.Rwp
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this quasi-experimental study is to compare the effectiveness of topical adrenaline and 3% hydrogen peroxide for controlling bleeding (hemostasis) during tonsil removal surgery in patients aged 5 to 18 years. The main questions it aims to answer are: 1. Which substance leads to faster bleeding control during surgery? 2. Which substance results in less total blood loss during surgery? Researchers compared the adrenaline group to the hydrogen peroxide group to see if one agent was more effective at managing bleeding than the other. Participants underwent a tonsillectomy where surgeons applied either gauze soaked in adrenaline (1:100,000 solution) or gauze soaked in 3% hydrogen peroxide to the tonsil area to stop bleeding.

Conditions

Chronic Tonsillitis; Tonsillar Hypertrophy, Tonsillitis; Tonsillectomy

Keywords

Tonsillectomy; Hemostasis, Surgical; Epinephrine; Hydrogen Peroxide; Intraoperative Complications; Administration, Topical; Otolaryngology

Outcome Measures

Primary Outcomes (2)

• Severity of intraoperative blood loss during tonsillectomy as classified by combined gravimetric and volumetric assessment.

  Total volume of blood lost during the surgical procedure, determined by the sum of blood volume calculated from the gravimetric method (pre- and post-operative weight of surgical gauze) and the volumetric method (suction canister volume). Results are categorized ordinally as: Mild (16-75 mL), Moderate (76-275 mL), or Severe (\>275 mL).

  Measured during the intraoperative period, specifically from the time of hemostatic agent application until the completion of the tonsillectomy procedure.

• Time to achieve intraoperative hemostasis during tonsillectomy as measured in minutes.

  Time from the application of the hemostatic agent until the complete cessation of bleeding from the tonsillar fossa, as recorded by the surgical team. Time is recorded in categorical intervals: \<1 minute, 1-3 minutes, 3-5 minutes, and \>5 minutes.

  Measured during the intraoperative period, specifically from the time of hemostatic agent application until the completion of the tonsillectomy procedure.

Study Arms (2)

Adrenaline Group

ACTIVE COMPARATOR

Participants in this group receive topical application of adrenaline (1:100,000 solution) via gauze pieces immediately following the removal of tonsils during the surgical procedure to achieve hemostasis.

Drug: Adrenaline

Hydrogen Peroxide Group

ACTIVE COMPARATOR

Participants in this group receive topical application of 3% hydrogen peroxide via gauze pieces immediately following the removal of tonsils during the surgical procedure to achieve hemostasis.

Drug: Hydrogen Peroxide

Interventions

Hydrogen Peroxide DRUG

Topical application of 3% hydrogen peroxide solution.

Also known as: H2O2

Hydrogen Peroxide Group

Adrenaline DRUG

Topical application of 1:100,000 adrenaline solution.

Also known as: Epinephrine

Adrenaline Group

Eligibility Criteria

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

You may qualify if:

• Patients aged 5-18 years.
• Scheduled for elective tonsillectomy.
• Diagnosis of chronic or recurrent tonsillitis.
• Normal coagulation profile.
• Medically fit for general anesthesia.
• Provided informed consent (from participant, or parent/legal guardian for pediatric participants).

You may not qualify if:

• Patients with a coagulation or bleeding disorder.
• Patients taking blood-thinning medications (e.g., aspirin or other antiplatelet agents).
• Presence of an acute tonsillar infection at the time of surgery.
• Known reaction or allergy to adrenaline or hydrogen peroxide.
• Known or suspected tonsillar malignancy.
• Concurrent adenoid hypertrophy requiring adenoidectomy.

Sponsors & Collaborators

• Rawalpindi Medical College: lead

Study Sites (1)

Rawalpindi Teaching Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (1)

• Hsieh CY, Hsu CJ, Wu HP, Sun CH. Comparison Benefit between Hydrogen Peroxide and Adrenaline in Tonsillectomy: A Randomized Controlled Study. J Clin Med. 2022 May 11;11(10):2723. doi: 10.3390/jcm11102723.

  PMID: 35628850 BACKGROUND

Related Links

• Clinical Practice Guideline: Tonsillectomy in Children. Provides the standard clinical guidelines for pediatric tonsillectomy, establishing the diagnostic and management context for the study population.

MeSH Terms

Conditions

Tonsillitis; Intraoperative Complications

Interventions

Epinephrine; Hydrogen Peroxide

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study utilized a single-blind design regarding the assessment of outcomes. Personnel responsible for evaluating intraoperative blood loss, including those weighing gauze and reading the suction canister volumes, were blinded to the group assignment of the participants. However, the operating surgeons and the surgical team were not masked, as they were required to know which hemostatic agent was being applied during the procedure to perform the intervention and record the time to hemostasis. Therefore, neither the participants, the care providers, nor the primary investigators were masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Efficacy of hydrogen peroxide Versus Adrenaline for Intraoperative Hemostasis During Tonsillectomy. A Quasi-Experimental Study

Model Details: The study employs a parallel group design with two distinct study arms: Group A (adrenaline) and Group B (hydrogen peroxide). Participants are assigned to one of these two groups based on their date of surgery-even-numbered dates for the adrenaline group and odd-numbered dates for the hydrogen peroxide group-and receive only their assigned intervention for the duration of the procedure.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: February 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)