Efficacy and blood concentrations of epidural hydromorphone (strong opioid) in labour

Efficacy and blood concentrations of epidural hydromorphone in labour

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000903-10-FI

Enrollment

Unknown

Registered

2016-09-15

Start date

2017-01-04

Completion date

Unknown

Last updated

2017-08-28

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

Conditions

Labour pain

Interventions

Product Name: Palladon Pharmaceutical Form: Injection CAS Number: 71-68-1 Other descriptive name: HYDROMORPHONE HYDROCHLORIDE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: healthy primipara age 18-45 years normal fullterm bregnancy wish for epidural pain relief no contraindications to epidural or hyrdomorphone no regular opioid-treatment no opioids during last 12 hours Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: immediate need for pain relief sleep apnea or lung dysfunction BMI > 35 kg/m2 organ dysfunction alcohol abuse MAO-inhibitor use elevated intracranial pressue hydromorphone allergy

Design outcomes

Primary

Measure	Time frame
Main Objective: to improve treatment of labour pain. Study the pharmacodynamics of epidural hydromorphone bolus according to blood concentrations. ;Secondary Objective: Effect and duration of single dose hydromorphone side-effects neurologic and adaptive capacity scoring system for evaluating new born babies (NACS-evaluation);Primary end point(s): blood concentration of hydromorphone from mother during the labour and from umpilical vein and artery after birth;Timepoint(s) of evaluation of this end point: from mother: 0, 15, 30, 45, 60 min, 2h, 3h, 4h and then every 2 hours until birth after umbilical cord cutting blood exam from umbilical vein and artery	—

Measure

Time frame

Main Objective: to improve treatment of labour pain. Study the pharmacodynamics of epidural hydromorphone bolus according to blood concentrations. ;Secondary Objective: Effect and duration of single dose hydromorphone side-effects neurologic and adaptive capacity scoring system for evaluating new born babies (NACS-evaluation);Primary end point(s): blood concentration of hydromorphone from mother during the labour and from umpilical vein and artery after birth;Timepoint(s) of evaluation of this end point: from mother: 0, 15, 30, 45, 60 min, 2h, 3h, 4h and then every 2 hours until birth after umbilical cord cutting blood exam from umbilical vein and artery

—

Secondary

Measure	Time frame
Secondary end point(s): Effect and duration of single dose hydromorphone side-effects neurologic and adaptive capacity scoring system for evaluating new born babies (NACS-evaluation);Timepoint(s) of evaluation of this end point: pain NRS: before epidural hydromorphone, and afterward every 15 minutes (rest and contraction pain) nausea NRS every 15 min NACS 30-60min after birth	—

Countries

Finland

Contacts

Public ContactDepartment of Anesthesiology

Oulu University Hospital

terhi.puhto@ppshp.fi

Outcome results

None listed

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