Cortical and hormonal stress responses to pain management with morphine in standard clinical dosage

• Conditions: eonatal pain; MedDRA version: 12.1Level: LLTClassification code 10056350Term: Pain management; MedDRA version: 12.1Level: LLTClassification code 10022519Term: Intensive care; MedDRA version: 12.1Level: LLTClassification code 10029392Term: Newborn

• Registration Number: EUCTR2009-015659-26-SE
• Lead Sponsor: Karolinska Institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Need for neonatal intensive care, including need for chest tube
2.Newborn infant with a clinical indication of morphine analgesia
3.Postnatal age < 4 weeks
4.Arterial catheter (peripheral or umbilical), as clinically indicated
5.Parental consent

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

1.Major chromosomal anomaly
2.Neonatal encephalopathy
3.Need for muscular paralysis
4.Need for surgery
5.Concurrent medication with other pain-reducing medications, e.g. paracetamol
6.Clinical or biochemical evidence of hepatic and renal failure, or treatment with drugs that are UGT2B7 and/or CYP3A4 substrates (e.g. NSAID and fluconazyl, respectively, please see separate list)

Study & Design

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