DACAA: Modality of Pain Management in Ambulatory Tonsillectomy Surgery in Adults

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04853173
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
18
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Assess pain management modalities in adult outpatient tonsillectomy surgery
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Assess pain management modalities in adult outpatient tonsillectomy surgeryAssess pain management modalities in adult outpatient tonsillectomy surgery
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Modality of Pain Management in Ambulatory Tonsillectomy Surgery in Adults: External Pilot Study
Anticipated Study Start Date :
May 28, 2021
Anticipated Primary Completion Date :
Nov 28, 2022
Anticipated Study Completion Date :
Nov 28, 2022

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. 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. [14 days]

    Pain measured by self-assessment by Analog Visual Scale (0-10). If score is under 4 = efficacity of ansthesia protocol

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1CHU BesançonBesançonFrance25000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT04853173
Other Study ID Numbers:
  • 2020/542
First Posted:
Apr 21, 2021
Last Update Posted:
Apr 22, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 22, 2021