I.Primary research question: a.) What is the influence of anaesthesia during a surgical day care procedure in a young child concerning: 1. postoperative development of sensory stimulus processing (measured with the Infant/Toddler Sensory Profile (I/T SP))
Conditions
Interventions
This study is a longitudinal case-control research in 200 children aged between 18 and 30 months, divided in:
1. An intervention group (n = 100)
2. A control group (n = 100).
The intervention group undergoes an intervention under anaesthesia in the day care hospital of the Queen Paola Children’s Hospital. The control group of 100 children, m
Sponsors
Department of Anaesthesia
ZNA Middelheim -Koningin Paola Kinderziekenhuis
Lindendreef 1
2020 Antwerpen/Belgie
secretary: 032803981
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age from 18 up to and including 30 months and of male sex (intervention and control group); 2. Healthy children without a medical record or congenital disorders (intervention and control group); 3. Children who undergo a circumcision under anaesthesia because of religious reasons in the day care hospital; 4. Written permission (Informed consent); 5. Parents who speak and understand Dutch; 6. Accompanying parent during induction anaesthesia.
Exclusion criteria
Exclusion criteria: 1. No previous medical/surgical interventions under anaesthesia in the child (both intervention and control group); 2. Children who need a circumcision because of medical reasons; 3. No previous hospital admissions of the child (both intervention and control group); 4. All kinds of known limitations among which an intellectual limitation, speech or language defect, autism/pervasive development disorder (PDD), delayed development, … they are all mentioned on the score form of the I/TSP-Nl 7 up to and including 36 months; 5. Parents and children who do not speak and understand Dutch; 6. Parents who do not give permission for the research.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The secundairy outcome measures: 1. The VAS scores of the child’s anxiety at induction perceived by parent as well as the research nurse and anaesthetist; 2. The ED scores by means of the Watcha scale; 3. The pain scores of the nurses by means of the FLACCnurse scale and the pain scores of the parents by means of a VASpain perception parents and VASnurse scale. | — |
Primary
| Measure | Time frame |
|---|---|
| The principal outcome measures are: The changes measured with the I/TSP – NL 7-36 months and the CBCL 11/2- 5 in the intervention group compared to the control group. | — |
Contacts
Public ContactJ. Berghmans
ZNA Middelheim - Koningin Paola Kinderziekenhuis Lindendreef 1
Outcome results
None listed