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

K

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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