Wound catheter infusion after abdominal surgery in baby's.

Phase 1

• Conditions: MedDRA version: 20.1Level: PTClassification code 10062022Term: Intestinal atresiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Children < 1 year of age undergoing major open abdominal surgery.; MedDRA version: 20.1Level: PTClassification code 10021298Term: Ileal atresiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.1Level: PTClassification code 10010526Term: Congenital large intestinal atresiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.1Level: PTClassification code 10002120Term: Anal atresiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.1Level: PTClassification code 10010626Term: Congenital small intestinal atresiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.1Level: PTClassification code 10013812Term: Duodenal atresiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.1Level: PTClassification code 10028210Term: Multiple gastrointestinal atresiasSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-002209-12-NL
• Lead Sponsor: Erasmus MC-Sophia Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-12
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 days 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:
oAllergy to local anesthetics
oLocal or general infection (sepsis)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified