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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05915559
Other study ID # PI2022_843_0115
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date November 2024

Study information

Verified date June 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Nathalie KLOPP-DUTOTE, MD
Phone 03.22.08.80.51
Email Klopp.Nathalie@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Tonsillectomy is a frequent surgical procedure in the ENT specialty but it can be a source of postoperative pain that can be important. These pains complicate the intake of food and in particular the intake of analgesic drugs per os and require the prolongation of the hospitalization in order to continue an intravenous analgesia. The aim is to set up a protocol for ambulatory care of adult tonsillectomies. Then, it would allow an improvement of the postoperative quality of life for the patient, who prefers a quicker return home.The study aims to allow patients to come back home early after tonsillectomies with intravenous analgesia. Pain, feeding and quality of life will be evaluated regularly through an application called MAELA during a few days after surgery. They will also be evaluated by nurses coming via providers.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Indication for a tonsillectomy defined in the French recommendations - Age between 18 and 60 yo - Providing free and informed consent to participate - Having a smartphone able to process MAELA application - Affiliation to french social security

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Tonsillectomy
Tonsillectomy
Other:
daily follow-up
daily follow-up of clinical parameters (pain, feeding) and analgesia adapted to the pain

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (3)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens Centre Hospitalier Abbeville, Centre Hospitalier de Beauvais

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients EVA score less or equal at 3 EVA score is a pain scale from 0 to 10. 10 is the highest pain level. day 1
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