Efficacy of Hydrogen Peroxide Versus Adrenaline for Intraoperative Hemostasis During Tonsillectomy. A Quasi-Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Severity of intraoperative blood loss during tonsillectomy as classified by combined gravimetric and volumetric assessment.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 5 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Severity of intraoperative blood loss during tonsillectomy as classified by combined gravimetric and volumetric assessment.
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点
研究者
Muhammad Ali Javed
Efficacy of hydrogen peroxide Versus Adrenaline for Intraoperative Hemostasis During Tonsillectomy. A Quasi-Experimental Study
Rawalpindi Medical College
