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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-015659-26-SE
Enrollment
Unknown
Registered
2009-12-29
Start date
2010-01-22
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal pain MedDRA version: 12.1 Level: LLT Classification code 10056350 Term: Pain management MedDRA version: 12.1 Level: LLT Classification code 10022519 Term: Intensive care MedDRA version: 12.1 Level: LLT Classification code 10029392 Term: Newborn

Interventions

Trade Name: Morfin Special 0,4 mg/ml Pharmaceutical Form: Solution for infusion CAS Number: 52-26-6 Other descriptive name: MORPHINE HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Co

Sponsors

Karolinska Institutet
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Primary end point(s): Primary Endpoints To investigate cortical hemodynamic responses, measured with near infrared spectroscopy (NIRS), in relation to validated pain scores in newborn infants requiring intensive care treatment. Secondary Endpoints 1. To investigate cortical hemodynamic responses (NIRS) in relation to blood levels of stress hormones. 2. To investigate the feasibility of the pilot study protocol in preparation for the main clinical study. ;Main Objective: Evaluate cortical and hormonal responses to pain management with morphine ;Secondary Objective: to perform a feasibility study as preparation for the main clinical study in this EU funded programme.—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026