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Completed

NCT Number: NCT00685672

Safety of Epidural Fentanyl and Adrenalin During Childbirth

Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural solution given to women in childbirth

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Key information

Conditions

Pregnancy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Akershus University Hospital, Lørenskog, Norway

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About this study

Healthy women with indication for labor epidural at the Labor Clinic, Rikshospitalet University Hospital, may be included. A randomized, placebocontrolled, double blind,comparison of epidural with and without adrenalin. Outcome: Length of birth, quality of pain relief, total amount of epidural solution injected, and plasma concentration of fentanyl.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women at term in active labor

Exclusion criteria

  • age below 18 years
  • BMI > 40
  • drug hypersensitivity

Treatment and study plan

adrenalin

Drug

adrenalin 2 microgram pr ml placebo

Placebo

Drug

Saline instead of adrenaline in the epidural mixture

Primary outcomes

  1. Plasma concentration of fentanyl

    Time frame: hours

Secondary outcomes

  1. length of active labor

    Time frame: hours

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University Hospital, Akershus

Registry information

Official study title

Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
May 28, 2008
Registry last updated
Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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