Pain treatment of newborns: paracetamol rectal versus intraveneous administration, an open randomised clinical trial.
Phase 2
Completed
- Conditions
- pijnpainsuffer
- Registration Number
- NL-OMON35587
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1. gestational age > 26 weeks
2. weight at birth for gestational age < p97
3. necessity for pain treatment (Comfortneoscore >/<= 14)
A minimum of 48 hours persistent pain treatment is required
Exclusion Criteria
1. no necessity for pain treatment
2. macrosomia (weight at birth > p 97)
3. (severe) congenital abnormalities
4. less than 48 hours pain treatment is required
5. neonates are sedated or paralysed (Comfortneoscore impossible)
6. severe asphyxia (Apgar score < 4 after 5 minutes)
7. hepatic- and renal failure (at first blood screening)
8. rectal blood loss
9. necrotizing enterocolitis (active fase)
10. severe thrombocytopenia (< 50 x 10 9/l)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Paracetamol administered rectally versus intraveneously in neonates<br /><br><br /><br>Pharmacokinetics<br /><br>Optimal therapeutic dose<br /><br>Toxicity (renal and hepatic)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Paracetamol as administered rectally versus intraveneously in neonates<br /><br><br /><br>Pharmacodynamics</p><br>