Chronic TonsillitisNCT07675278
Comparing Two Agents Used to Stop Bleeding During Tonsil Removal Surgery: Adrenaline Versus Hydrogen Peroxide
A study testing Adrenaline and Hydrogen Peroxide in people with Chronic Tonsillitis and Tonsillar Hypertrophy, Tonsillitis, run by Rawalpindi Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Chronic Tonsillitis, Tonsillar Hypertrophy, Tonsillitis, Tonsillectomy
- What is being tested?
- Adrenaline and Hydrogen Peroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rawalpindi Teaching Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: Efficacy of Hydrogen Peroxide Versus Adrenaline for Intraoperative Hemostasis During Tonsillectomy. A Quasi-Experimental Study
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.
Read the 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.
- Being tested
- Adrenaline, Hydrogen Peroxide
- Keywords
- Tonsillectomy, Hemostasis, Surgical, Epinephrine, Hydrogen Peroxide, Intraoperative Complications, Administration, Topical, Otolaryngology
- Medical subject headings
- Tonsillitis, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrenalineDrug
Also called Epinephrine
Topical application of 1:100,000 adrenaline solution.
Hydrogen PeroxideDrug
Also called H2O2
Topical application of 3% hydrogen peroxide solution.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Hydrogen Peroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: Measured during the intraoperative period, specifically from the time of hemostatic agent application until the completion of the tonsillectomy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Feb 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic TonsillitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Ali Javed, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675278
- Sponsor's protocol ID
- 4824/RTH.Rwp
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35628850
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hydrogen Peroxide Versus Adrenaline for Intraoperative Hemostasis During Tonsillectomy. A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07675278
- Acronym / sponsor ID
- 4824/RTH.Rwp
- Keywords
- Tonsillectomy, Hemostasis, Surgical, Epinephrine, Hydrogen Peroxide, Intraoperative Complications, Administration, Topical, Otolaryngology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adrenaline Group | Active comparator | Drug: AdrenalineParticipants 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 | Drug: Hydrogen PeroxideParticipants 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients aged 5-18 years.
- Scheduled for elective tonsillectomy.
- Diagnosis of chronic or recurrent tonsillitis.
- Normal coagulation profile.
- Medically fit for general anesthesia.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdrenalineAlso: EpinephrineTopical application of 1:100,000 adrenaline solution. | Drug | Adrenaline Group |
| Hydrogen PeroxideAlso: H2O2Topical application of 3% hydrogen peroxide solution. | Drug | Hydrogen Peroxide Group |
Primary outcome
Severity of intraoperative blood loss during tonsillectomy as classified by combined gravimetric and volumetric assessment.
Time frame: 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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Background: PubMed 35628850Hsieh 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.
- Clinical Practice Guideline: Tonsillectomy in Children. Provides the standard clinical guidelines for pediatric tonsillectomy, establishing the diagnostic and management context for the study population.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Related trials for Chronic Tonsillitis
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Recovery From Tonsil Surgery.
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Active, not recruitingObservational study
A Comparative Study of Monopolar Versus Bipolar Electrocautery Post Tonsillectomy Outcomes.
Chronic Tonsillitis
Active, not recruiting
Intracapsular Tonsillectomy in Adults
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Recruiting
The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.
Tonsillitis Chronic, Tonsillitis Recurrent
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adrenaline and Hydrogen Peroxide in people with Chronic Tonsillitis and Tonsillar Hypertrophy, Tonsillitis, run by Rawalpindi Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of intraoperative blood loss during tonsillectomy as classified by combined gravimetric and volumetric assessment. (time frame: Measured during the intraoperative period, specifically from the time of hemostatic agent application until the completion of the tonsillectomy procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07675278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.