Study on the Efficacy and Safety of a Device for Post-op Recovery in Pediatric Adenectomy/Adenotonsillectomy.

Launched by PHARMALUCE SRL · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a medical device called Munatoril® Aerosol Combo to see if it helps children recover better after undergoing adenoidectomy or adenotonsillectomy surgeries, which are common procedures to remove the adenoids or tonsils. The study will compare the effectiveness and safety of this device to two other solutions that can be bought over-the-counter, one of which is a hypertonic saline solution. Researchers will look at how well children feel and how their condition improves over time, checking in with them at various points after surgery.

To participate in this trial, children aged 2 to 17 years who are scheduled for these surgeries may be eligible, as long as they meet certain criteria. For example, they should not have any allergies to the study's ingredients or recent respiratory infections. Families will be informed about the study and must sign consent forms. Participants will be monitored for 30 days after their surgery to track their recovery and any side effects. This trial is designed to provide valuable information that could help improve recovery for young patients undergoing these types of surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients of either sex aged 2 to 17 years who are candidates for adenoidectomy or adenotonsillectomy surgery.
• • Acquisition and signing of informed consent by the legal guardian.
• Exclusion Criteria:
• • Syndromic patients.
• • Patients allergic to any substance in the study formulations.
• • Patients who have used intranasal corticosteroids, topical or systemic corticosteroids, or any intranasal medication in the week prior to study entry.
• • Active respiratory infection in the 2 weeks prior to study entry.
• • Patients with a history of chronic epistaxis or immunodeficiency.