Topical 15% Trichloroacetic Acid Versus Silver Nitrate Cauterization in the Management of Idiopathic Childhood Epistaxis: A Prospective Double-Blinded, Randomized Clinical Trial

NCT06836791 | Completed DMC

• 1 other identifier: KFSIRB200
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

the invistigators aim to explore the efficacy of trichloroacetic acid as a chemical cauterization agent and compare it with that of silver nitrate in the treatment of idiopathic epistaxis in children.

Conditions

Anterior Epistaxis

Outcome Measures

Primary Outcomes (1)

• rebleeding from the nose

  Patients were followed at regular visits at the 1st, 2nd, 4th, and 12th week intervals. The main outcomes after chemical cauterization were rebleeding from the nose if present during or after the procedure. The success of post chemical cauterization was assessed through the complete cessation of epistaxis. Patients with reported recurrence of bleeding from the nose within 12 weeks of intervention were considered to have failed. rebleeding assessed according to number of bleeds and severity of the attacks.

  12 weeks

Secondary Outcomes (1)

• pain after procedure

  7 days after caurication

Study Arms (2)

Silver nitrate group

EXPERIMENTAL

All procedures were performed as office-based procedures under the influence of local anesthesia. Group (A) Silver nitrate group: Patients were treated with silver nitrate chemical cauterization. Prior to cauterization, 2 cotton packs soaked in 10% lignocaine spray were introduced into each nostril for 5-10 minutes. Then, a cotton-tipped applicator dipped in 25% silver nitrate solution was applied to the bleeding point, and the sample was firmly pressed for 1 minute. In the case of bleeding, a second application of silver nitrate solution was applied to the area, after which a cotton tip applicator was applied to the area for 30 s with cauterization of all the feeding blood vessels around the bleeding point. This was followed by the prescription of an antiseptic soothing cream topically twice daily for 2 weeks.

Procedure: chemical cautrizating agents to stop epistaxis; Drug: Silver Nitrate

Trichloroacetic acid group

EXPERIMENTAL

Group (B) The TCA group: Patients underwent chemical cauterization with 15% TCA solution via the same technique. If there was active nasal bleeding, prior to cauterization, a cotton pack soaked in a nasal decongestant such as oxymetazoline or a 10% lignocaine spray was introduced into the nostril for 5-10 minutes. Patients were offered topical antiseptics for two weeks. Both groups were offered analgesics according to their condition.

Procedure: chemical cautrizating agents to stop epistaxis; Drug: Trichloroacetic Acid Topical

Interventions

chemical cautrizating agents to stop epistaxis PROCEDURE

All procedures were performed as office-based procedures under the influence of local anesthesia.Patients were treated with chemical cauterization. Prior to cauterization, 2 cotton packs soaked in 10% lignocaine spray were introduced into each nostril for 5-10 minutes. Then, a cotton-tipped applicator dipped in chemical cautrizating agents solution was applied to the bleeding point, and the sample was firmly pressed for 1 minute. In the case of bleeding, a second application of chemical cautrizating agents solution was applied to the area, after which a cotton tip applicator was applied to the area for 30 s with cauterization of all the feeding blood vessels around the bleeding point. This was followed by the prescription of an antiseptic soothing cream topically twice daily for 2 weeks.

Silver nitrate group; Trichloroacetic acid group

Silver Nitrate DRUG

silver nitrate is chemical cautrizing agent ,in the study ,the investigators use it in treatment of anterior epistaxis in children by dissolving silver nitrate crystals in normal saline solution before using.

Silver nitrate group

Trichloroacetic Acid Topical DRUG

trichloroacetic acid is well known peeling agent ,in the study the investigators use it as chemical cautrizing agent to treat anterior epistaxis in children .

Also known as: TCA

Trichloroacetic acid group

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All patients aged between 4 and 16 years at least once weekly in the last 4 weeks with visible anterior bleeding sources either unilateral or bilateral from Little's area were included in the study.

You may not qualify if:

• All patients with documented coagulopathy, those with sinonasal or nasopharyngeal masses, those with active rhinosinusitis or severe allergic rhinitis or severe septal deviation

Sponsors & Collaborators

• Youssef Zaki: lead
• Kafrelsheikh University: collaborator

Study Sites (1)

Kafrelsheikh University

Kafrelsheikh, Kafrelsheikh, Egypt

Location

MeSH Terms

Interventions

Silver Nitrate; Trichloroacetic Acid

Intervention Hierarchy (Ancestors)

Nitrates; Nitric Acid; Nitrogen Compounds; Inorganic Chemicals; Silver Compounds; Chloroacetates; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: This was a prospective, randomized, double-blinded study that was held at our tertiary referral center, Otorhinolaryngology Department, Kafrelsheikh University, Egypt. All patients' parents or assigned caregivers signed written informed consent for participation in this trial. Patients who sought help complaining of recurrent epistaxis episodes either with or without active bleeding at the time of presentation were invited to participate in the study. All patients aged between 4 and 16 years with at least once weekly in the last 4 weeks with visible anterior bleeding sources either unilateral or bilateral from Little's area were included in the study.

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 20, 2025
• Study Start: March 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 2, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

EG (1)