Chronic Tonsillitis, Tonsillar Hypertrophy, Tonsillitis, Tonsillectomy
Conditions
Keywords
Tonsillectomy, Hemostasis, Surgical, Epinephrine, Hydrogen Peroxide, Intraoperative Complications, Administration, Topical, Otolaryngology
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.
Detailed 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.
Interventions
DRUGAdrenaline
Topical application of 1:100,000 adrenaline solution.
Topical application of 3% hydrogen peroxide solution.
Sponsors
Rawalpindi Medical College
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of intraoperative blood loss during tonsillectomy as classified by combined gravimetric and volumetric assessment. | Measured during the intraoperative period, specifically from the time of hemostatic agent application until the completion of the tonsillectomy procedure. | 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). |
| Time to achieve intraoperative hemostasis during tonsillectomy as measured in minutes. | Measured during the intraoperative period, specifically from the time of hemostatic agent application until the completion of the tonsillectomy procedure. | 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. |
Countries
Pakistan
Outcome results
None listed