|- candidate number||14740|
|- NTR Number||NTR3955|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-apr-2013|
|- Secondary IDs||OG 009;031 E.C. Approval nr. 4157 B009201317117|
|- Public Title||DE INVLOED VAN PREOPERATIEF EMOTIONEEL EN GEDRAGSMATIG FUNCTIONEREN VAN KINDEREN TUSSEN 1.5 EN 5 JAAR OP POSTOPERATIEVE PIJN NA ADENOTONSILLECTOMIE IN DAGZIEKENHUIS.
EEN PROSPECTIEF COHORT ONDERZOEK.
|- Scientific Title||THE INFLUENCE OF PREOPERATIVE EMOTIONAL AND BEHAVIORAL FUNCTIONING OF CHILDREN BETWEEN 1.5 AND 5 ON POSTOPERATIVE PAIN AFTER ADENOTONSILLECTOMY IN DAY CARE.
A PROSPECTIVE COHORT STUDY.
|- ACRONYM||CBCL - A/AT- POK 1.5-5|
|- hypothesis||The purpose of this research is to acquire a better understanding of the pain experience and the recovery of children between 1.5 and 5 years old who underwent a tonsillectomy/adenotonsillectomy.
Primary research question:
What is the influence of emotional and behavioral functioning (externalizing/internalizing) six months prior to surgery of a child between 1.5 and 5 years old undergoing a tonsillectomy/adenotonsillectomy on the measured postoperative pain scores by the parents and by the child itself?
1. Using the Parents' Postoperative Pain Measure (PPPMaccompanying-parent);
2. Using a Visual Analogue Scale (VASparent-pain-child-at-home) for the parent.
Secondary research questions:
1. What is the relation between the preoperative anxiety of the child and the parent by means of a Visual Analogue Scale (VASanxiety-parent-preoperative) and the postoperative pain scores in day care (VASparent-child-pain-in hospital) and the scores at home during three days (VASparent-child-pain-at-home)?
2. What is the influence of the difference between high versus low pain scores of children (with a cut-off ≥ 4 VASparent-child-pain-at-home) on the administration of analgesics?
Furthermore this research focuses on the following additional questions:
1. What is the correlation between VASparent-child-pain-at-home on the one hand and the PPPMaccompanying-parent during three days postoperative on the other hand?
2. What is the Intraclass Correlation Coefficient (ICC) between pain measured by the both parents by means of a VASparent-child-pain-at-home during three days postoperative?
3. What is the ICC between the PPPM measurements of both parents during three days postoperative?
4. What is the influence of the state and trait anxiety of the accompanying parent measured with the Spielberger's State-Trait Anxiety Inventory (STAI) on the postoperative pain measurement and the administration of analgesics of the child?
5. What is the influence of the need for information (information seeking versus information avoiding behavior), of the accompanying parent measured with the Amsterdam Preoperative Anxiety Information Scale (APAIS) on the postoperative pain measurement and the administration of analgesics of the child?
6. What is the correlation between VASparent-child-pain-in-hospital on the day of surgery and the pain assessments on the Face, Legs, Activity, Cry, Consolability Scale (FLACC) measured by an independent nurse (FLACCnurse) in the postoperative section of the day care?
7. What is the relation between preoperative externalizing/internalizing problems measured with the Child Behavior Checklist (CBCL 1.5-5), the anxiety of the child at induction measured with the modified Yale Preoperative Anxiety Scale (T3mYPAS) and emergence delirium at awakening from anesthesia measured with the Pediatric Anesthesia Emergence Delirium scale (PAEDsum scores at T1-T2-T3)?
8. Identifying sleeping problems of the child (falling asleep, waking up, nightmares) during three days postoperative by using a few specific questions concerning sleeping disorders of the Post Hospitalisation Behavioral Questionnaire (PHBQ).
9. Validation of translated behavior observation instruments (PPPM, FLACC, mYPAS, a few questions of the PHBQ).
|- Healt Condition(s) or Problem(s) studied||Children, Post-operative pain|
|- Inclusion criteria||1. From 1.5 to and including 5 years old;|
2. Surgery: tonsillectomy or combined adenotonsillectomy;
3. Information and consent forms and assent form explained to the child;
4. Accompanying parent present at induction;
5. Parents who speak and understand Dutch;
6. No premedication (the norm in Queen Paola Children’s Hospital).
|- Exclusion criteria||1. Known mental/cognitive retardation;|
2. American Society Anesthesiologists ASA physical status > II;
3. Children with objectified obstructive sleep apnea syndrome;
4. Children with BMI > 25;
5. Allergic reaction to sevoflurane and/or risk of malign hyperthermia.
Secundary exclusion criteria:
1. When parent or child no longer wish to participate;
2. When a life-threatening situation occurs during the procedure (f.i. asystole);
3. When re-intervention is required as a result from subsequent bleeding;
4. When the child has to be admitted because of constant nausea/vomiting.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||19-apr-213|
|- planned closingdate||31-dec-2014|
|- Target number of participants||160|
|- Interventions||Observation - no intervention.|
|- Primary outcome||1. The scores of the Parents’ Postoperative Pain Measure (PPMPaccompanying parent) during three days postoperative;|
2. Assessment of the pain scores by the child and the parent by means of a Visual Analogue Scale (VAS parent-child-pain-at home) for the accompanying parent during three days postoperative.
|- Secondary outcome||1. The pain scores of the child and the accompanying parent in the postoperative day care and by means of a Visual Analogue Scale (VASparent-child-pain-in-hospital) for the parent;|
2. The pain scores measured by the FLACCnurse;
3. The total administration of analgesics at home (as noted in the diary) during three days and at day ten postoperative.
|- Timepoints||Day of surgery, three days postoperative and day ten postoperative.|
|- Trial web site||www.zna.be|
|- CONTACT FOR PUBLIC QUERIES|| M. Vel, de|
|- CONTACT for SCIENTIFIC QUERIES|| J. Berghmans|
|- Sponsor/Initiator ||ZNA Middelheim - Koningin Paola Kinderziekenhuis, Department of Anaesthesia|
(Source(s) of Monetary or Material Support)
|ZNA Middelheim - Koningin Paola Kinderziekenhuis, Department of Anaesthesia|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||16-apr-2013 - 27-apr-2013|