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

Rawalpindi Medical University

Status: Completed

Conditions: Tonsillectomy; Chronic Tonsillitis; Tonsillar Hypertrophy, Tonsillitis

Treatments: Drug: Adrenaline; Drug: Hydrogen Peroxide

Study type: Interventional

Funder types: Other

Identifiers

NCT07675278

4824/RTH.Rwp

Details and patient eligibility

About

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.

Full description

This study was conducted as a quasi-experimental comparative analysis to evaluate the efficacy of two common topical hemostatic agents, adrenaline (1:100,000 solution) and 3% hydrogen peroxide, during elective tonsillectomy. All procedures were performed in the Department of Otorhinolaryngology at Rawalpindi Teaching Hospital. Surgeons of a consistent training level performed all tonsillectomies using the dissection technique to minimize inter-operator variability. The allocation of patients to either the adrenaline or hydrogen peroxide group was determined by the surgical date (even-numbered dates for adrenaline; odd-numbered dates for hydrogen peroxide). To maintain measurement rigor, blood loss was assessed by personnel blinded to the group assignment, utilizing both gravimetric and volumetric methods. The dry weight of standard surgical gauze was recorded preoperatively and compared against the weight of blood-soaked gauze post-use to estimate blood volume, utilizing a blood specific gravity of 1.055 g/mL. Additionally, suction canister volumes were measured, with adjustments made for any irrigation fluid used during the procedure. Intraoperative hemostasis was defined as the complete cessation of bleeding from the tonsillar fossa without the requirement for further hemostatic intervention. Time to achieve hemostasis was recorded by the operating team and categorized into four intervals: <1 minute, 1-3 minutes, 3-5 minutes, and >5 minutes. Total intraoperative blood loss was calculated as the aggregate of the gravimetric (gauze) and volumetric (suction) assessments and was ordinally classified as mild (16-75 mL), moderate (76-275 mL), or severe (>275 mL). Statistical analysis was performed using IBM SPSS Statistics version 25.0, employing the Mann-Whitney U test for non-normally distributed time-to-hemostasis data and the Chi-square test for ordinal blood loss categories.

Enrollment: 64 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Adrenaline Group

Active Comparator group

Description:

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.

Treatment:

Drug: Adrenaline

Hydrogen Peroxide Group

Active Comparator group

Description:

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.

Treatment:

Drug: Hydrogen Peroxide