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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adrenaline | Drug | Topical application of 1:100,000 adrenaline solution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rawalpindi Teaching Hospital | Rawalpindi | Punjab Province | 46000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35628850 | Background | 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. |
| Label | URL |
|---|---|
| Clinical Practice Guideline: Tonsillectomy in Children. Provides the standard clinical guidelines for pediatric tonsillectomy, establishing the diagnostic and management context for the study population. | View source |
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Individual participant data (IPD) will not be made publicly available as part of a general data-sharing plan; however, the data that support the findings of this study are available from the corresponding author upon reasonable request.
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| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| D007431 | Intraoperative Complications |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D006861 | Hydrogen Peroxide |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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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.
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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.
| Hydrogen Peroxide | Drug | Topical application of 3% hydrogen peroxide solution. |
|
|
| D009057 |
| Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010545 | Peroxides |
| D010087 | Oxides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D017601 | Oxygen Compounds |