The hypothesis is that an epidural pain treatment for adolescents is more effective as postoperative pain treatment following an epiphysiodesis procedure compared to a post operative pain treatment with intraveneus PCA method.
ID
Bron
Verkorte titel
Aandoening
postoperative pain following an epiphysiodesis procedure of both legs for adolescents
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Number rating scale for pain during the first 5 days postsurgery
Doel van het onderzoek
The hypothesis is that an epidural pain treatment for adolescents is more effective as postoperative pain treatment following an epiphysiodesis procedure compared to a post operative pain treatment with intraveneus PCA method.
Onderzoeksopzet
Primary outcome: day 1-5 postsurgery
Secondary outcome: at 2 weeks, 6 weeks and 6 months
Onderzoeksproduct en/of interventie
a) epidural pain management: bupivacain 5mg/hour pump according to pain protocol for children of Máxima Medical Centre. The epidural pain protocol will be started at the beginning of the surgical procedure and will be 3 days in situ.
b) pain medication by intravenous PCA (pain pump): morfine 1mg/ml by pump with lockout time of 6 minutes and additional bolus of 1/2mg vaccording to pain protocol for children of Máxima Medical Centre.
Publiek
Max Reijman
Ds. Th. Fliednerstraat 1
Eindhoven 5631 BM
The Netherlands
telephone: 0031-40-8885257
emailadress: max.reijman@mmc.nl
Wetenschappelijk
Max Reijman
Ds. Th. Fliednerstraat 1
Eindhoven 5631 BM
The Netherlands
telephone: 0031-40-8885257
emailadress: max.reijman@mmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients should meet the following inclusion criteria: age between 12-16 year; “indication for epiphysiodesis”, namely boys for which the estimated final body length will be minimally 200 cm; for girls this will be 195 cm.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A patient should not meet the following exculison criteria: insufficient command of Dutch language; niet willing to participate; contraindications for surgery.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL5064 |
NTR-old | NTR5195 |
CCMO | NL50837.015.15 |
OMON | NL-OMON42155 |