Pain treatment of newborns: paracetamol rectal versus intraveneous administration, an open randomised clinical trial. - Pain treatment of newborns: paracetamol rectal versus intraveneous administration.

• Conditions: Pain treatment of neonates and premature neonates.

• Registration Number: EUCTR2009-011753-41-NL
• Lead Sponsor: eonatal intensive care unit, VU medical center Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Gestational age > 26 weeks
Weight at birth for gestational age < p97
necessity for pain treatment (Comfortneoscore >/= 14)
A minimum of 48 hours persistent pain treatment is required
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

No necessity for pain treatment
macrosomia (weight at birth > p 97)
(severe) congenital abnormalities
Less than 48 hours pain treatment is required
Neonates are sedated or paralysed (Comfortneoscore impossible)
severe asphyxia (Apgar score < 4 after 5 minutes)
Hepatic- and renal failure (at first blood screening)
Rectal blood loss
Necrotizing enterocolitis (active fase)
Severe thrombocytopenia (< 50 x 10 9/l)

Study & Design

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