Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03961581 |
| Other study ID # |
2019-02 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 30, 2019 |
| Est. completion date |
April 8, 2021 |
Study information
| Verified date |
July 2022 |
| Source |
Assistance Publique Hopitaux De Marseille |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The main objective of this study is to measure perioperative anxiety in children from 2 to 10
years old in two distinct homogeneous groups before and after the ride in electric cars
versus bed travel in the operating room.
The secondary objectives will be to measure the anxiety at the induction, the pain and the
agitation of the children in SSPI as well as the satisfaction and the lived experience of the
parents during the ambulatory stay of their child in the two groups journey in electric cars
versus trip in bed.
It is a prospective, randomized, single-centric observational study (small electric cars
versus bed-ridden), focusing on children during their stay in the operating theater at the
CHU Nord of Marseille for ENT and ophthalmic surgery.
This study on the use of electric cars as a means of locomotion within the block may lead to
other multicenter studies.
Description:
Peri operative anxiety is one of major issues of pediatric anesthesia. Our efforts to
decrease children anxiety improve pain, agitation ans behavioral changes during post
operative period. Guidelines in pediatric anesthesia are to take into account anxiety in
order to enhance recovery after anesthesia and to develop ambulatory surgery.
Pharmacological and non pharmacological tools are used. Midazolam is a benzodiazepin widely
used but its indesirable effects such as paradoxical reactions, prolonged sedation and
adverse behavioral changes are a brake to enhance recovery after anesthesia programs. Non
pharmacological procedures are more promising (parental presence, behavioral preparation
programs and distraction) but their etablishment is time consuming, requiring teaching
programs, and changing habits. To our knowledge, distraction with ride-on car has not been
studied yet.
Little electric car can carry children aged 2 years and more, it can be driven by children
under adult distant command. Weight is limited to 35 kg (x pounds). Our hospital has 3
differents car models which allow children to choose for their prefered one et to become part
of the adventure. Parental separation could be favored by this device.
Surgical procedures are ophtalmologic and oto rhino laryngologic, in an ambulatory ward
receiving children ASA 1 to 3. Anesthesic procedure is the same for every child, inhalatory
induction with sevoflurane following by perfusion for morphinic administration and oral
intubation. To note, premedication is avoided and replaced by important information and
reinsurrance of parents.
Chlidren will be randomised by block every week to go to operating room using gurney (goup a)
or ride-on electric car (group b). Primary outcome is peri operative pediatric anxiety
measured by Yale validated scale (m-YPAS). Other outcomes concern post opérative period
(anxiety, pain, agitation), parental lived and satisfaction.
PTIBOLID is a monocentric prospective randomised controlled open study wich will include 110
patients in hopital Nord, Marseille, AP-HM.
