The Effect of Oxycodone to the Placental Circulation at Early Labour (oksisynnII)

Kuopio University Hospital

Status and phase: Active, not recruiting; Phase 4

Conditions: Labor Pain

Treatments: Drug: Placebo; Drug: Oxycodone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02573831

KUH12012015

Details and patient eligibility

About

Oxycodone is used to treat pain in early labor, however the effect of oxycodone to placental or fetal circulation has not been evaluated. Oxycodone is increasingly used to treat labor pain in the early phase. The aim of the randomised, double blinded, placebo controlled study was to evaluate the effects of oxycodone in placental circulation, efficacy and safety of oxycodone and the effects to the newborn.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• oxycodone planned for pain relief

  • age 18 years or more
  • Informed consent obtained
  • Full term pregnancy

Exclusion criteria

• No oxycodone planned

  • age less than 18 years
  • No informed consent
  • not full term pregnancy

• Other contraindication to oxycodone

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The patients are given at first placebo and after one hour oxycodone 0,05 mg/kg if needed

Treatment:

Drug: Placebo

Oxycodone

Experimental group

Description:

The patients are given at first oxycodone 0,05 mg/kg and after one hour oxycodone 0,05 mg/kg if their pain in numerical rating scale from 0 to 10 is 5 or more

Treatment:

Drug: Oxycodone