- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04217941
Effect of Practical Demonstration to Use Nasal Spray and Apply Intranasal Ointment on Epistaxis
January 3, 2020 updated by: Ahmed Khan, Combined Military Hospital, Pakistan
Effect of Practical Demonstration to Use Nasal Spray and Apply Intranasal Ointment on Outcome, in Cases of Recurrent Pediatric Epistaxis
To compare the result of verbally educating the parents about method of intranasal antiseptic cream application versus practically educating and demonstrating how to apply cream intra nasally.
Study Overview
Status
Completed
Conditions
Detailed Description
The primary outcome variables was control of epistaxis through history and clinical examination on follow up visits
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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KPK
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Mardan, KPK, Pakistan
- CMH Mradan
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The children of age less than 12 years presenting with anterior recurrent epistaxis
Exclusion Criteria:
o Children with bleeding disorders.
- Children with liver and renal failure/dysfunction.
- Children using anti-coagulants.
- Those children who have gross deviated nasal septum or nasal polys etc.
- Cases who had history of nasal injuries secondary to trauma.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Health Education with practical demonstration
Participants assigned to the intervention arm received health education with practical demonstration of nasal spray and intranasal ointment .
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Health education with practical demonstration of medicine was compared to health education without practical demonstration
Other Names:
We compared the effect of Health education and practical demonstration for using nasal spray and apply intranasal ointment compared to health education without practical demonstration
Other Names:
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Placebo Comparator: Health education without practical demonstration
Participants assigned to the control arm received only health education regarding nasal spray and intranasal ointment .
|
Health education with practical demonstration of medicine was compared to health education without practical demonstration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of epistaxis episodes
Time Frame: 0ne month
|
Success rate was measured on number of epistaxis episodes after treatment.
The primary outcome variables was control of epistaxis through history and clinical examination on follow up visit
|
0ne month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
December 29, 2019
First Submitted That Met QC Criteria
January 3, 2020
First Posted (Actual)
January 6, 2020
Study Record Updates
Last Update Posted (Actual)
January 6, 2020
Last Update Submitted That Met QC Criteria
January 3, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMH-06-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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