ess opioids after major abdominal surgery in young infants using wound catheter infusion with local anesthetics: a randomized controlled trial.

Phase 3

Completed

Conditions: abdominal surgery in infants (for example for atresia of duodenum or jejunum)
10018008
10046400
10017998

Registration Number: NL-OMON47384

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:;- Informed consent;- Children < 1 year of age;- Minimal post-conceptual age of 35 weeks;- Minimal body weight of 1500 grams;- Abdominal (open) surgery

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:;- Withdrawal of informed consent;- Child with neurological disease, renal or hepatic dysfunction;- Chronic (more than one day) opioid or psychotropic drug (e.g. antiepileptics, benzodiazepines, antidepressants) exposure pre- or postnatal, in neonates (maximum 28 old) presenting for surgery, or < 1 month ago.;- Opioid exposure <24 hours before surgery;- Receiving ECMO therapy;- Known allergy / intolerance for paracetamol or morphine;- Contra-indications for regional analgesia techniques:;o Allergy to local anesthetics;o Local or general infection (sepsis)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective: Morphine sparing effect of WCI<br /><br>The mean cumulative amount of morphine administered over 48 hours<br /><br>postoperatively, in mcg/kg, will be compared in both groups (R group and<br /><br>control group).</p><br>

Secondary Outcome Measures