Modality of Pain Management in Ambulatory Tonsillectomy Surgery in Adults (DACAA)

Modality of Pain Management in Ambulatory Tonsillectomy Surgery in Adults: External Pilot Study

No SFORL recommendation for adult ambulatory tonsillectomy. This study would allow the establishment of an ambulatory management during an adult tonsillectomy. This would allow a return home from J0 for the patient and therefore would improve the comfort of the patients and reduce the cost associated with a conventional hospitalization over several days.

Study Overview

• Status: Recruiting
• Conditions: Tonsillar Disorder
• Intervention / Treatment: Other: Assess pain management modalities in adult outpatient tonsillectomy surgery

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurent TAVERNIER, PU-PH; Phone Number: 0381669360; Email: ltavernier@chu-besancon.fr

Study Locations

• France
  • Besançon, France, 25000
    • Recruiting
    • CHU Besançon
    • Contact: Laurent TAVERNIER; Phone Number: 0381669360; Email: ltavernier@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• programmed Tonsillectomy surgery

Exclusion Criteria:

• Congenital or acquired hemostasis disorder
• Indication of uvulo-bike-pharyngo-plasty
• Contraindication to the use of one of the protocol molecules including pregnancy
• Allergy to analgesic treatments used in the study
• Ongoing analgesic treatment that cannot be interrupted

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ambulatory protocol after adult tonsillectomy; prescription of analgesics for outpatient procedure with hospital surveillance	Other: Assess pain management modalities in adult outpatient tonsillectomy surgery; use a post-operative analgesia protocol suitable for outpatient surgery. Namely a protocol of analgesia based on the taking of drugs per bone (by mouth) and not intravenous. Pain evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess pain management modalities in ambulatory tonsillectomy surgery in adults through post-operative pain assessment, with a defined analgesia and anesthesia protocol adapted to ambulatory management.	Pain measured by self-assessment by Analog Visual Scale (0-10). If score is under 4 = efficacity of ansthesia protocol	14 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Anticipated): November 28, 2022
• Study Completion (Anticipated): November 28, 2022

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2020/542

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