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. 2022 May 13;2022(5):CD013525. doi: 10.1002/14651858.CD013525.pub2

NCT02678897.

Methods "Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment"
Participants "Inclusion Criteria:
  • Patients who choose medical method of abortion

  • First pregnancy

  • Age between 15 and 19 years or 25 and 35 years

  • Patients volunteer in the study


Exclusion criteria for inquiry part are
  • Patient's serious illness

  • Known allergy to one of the trial medications

  • Abortion is done based on foetal abnormality or threat of patient's own health


Exclusion criteria for intervention part are
  • Abortion is done based on foetal abnormality or threat of patient's own health

  • Minor patient does not want to inform guardian

  • More than one foetus

  • Patient's serious illness (ASA‐class 3 or 4)

  • Massive obesity (BMI >35 kg/m2)

  • Known allergy to one of the trial medications

  • History of opioid abuse

  • Problems of understanding (Inability of use PCA or to understand VAS)

  • Active bleeding before intake of first Misoprostol dose

  • One of next medications: ketokonatsol, erythromycin, claritromycin, verapamil or diltiazem or medication against HIV (CYP3A4‐transmitted interaction with oxycodon)"

Interventions "Drug: Oxynorm on‐demand
We compare different routes of administration (PCA an oral/intramuscular use of oxynorm) in patients undergoing medical termination of pregnancy. Patients are randomized in two groups (for extra pain medication)
  1. If analgesia is inadequate oxycodon (OxyNorm®) (10 mg (less than 80 kg) ‐ 15 mg (over 80 kg) po [orally]. In an hour oxycodon 5‐10 mg more po if needed. Intramuscular or intravenous administration if needed.

  2. Patient controlled analgesia (PCA pain pump): Oxycodon dose is 3.0 mg (3 ml) and lock‐out time 8 min. Maximum four doses in hour. Dose can be lowered or augmented 0,5 [0.5] mg at time between 2.0‐4.0 mg and maximal number of doses can be up to 5.

  • Drug: Oxynorm via PCA


We compare different routes of administration (PCA an oral/intramuscular use of oxynorm) in patients undergoing medical termination of pregnancy. Patients are randomized in two groups (for extra pain medication)
  1. If analgesia is inadequate oxycodon (OxyNorm®) (10 mg (less than 80 kg) ‐ 15 mg (over 80 kg) po. In an hour oxycodon 5‐10 mg more po if needed. Intramuscular or intravenous administration if needed.

  2. Patient controlled analgesia (PCA pain pump): Oxycodon dose is 3.0 mg (3 ml) and lock‐out time 8 min. Maximum four doses in hour. Dose can be lowered or augmented 0,5 [0.5] mg at time between 2.0‐4.0 mg and maximal number of doses can be up to 5."

Outcomes Primary outcomes: "Patients are less painful using patient controlled analgesia (PCA) [ Time Frame: During drug‐induced abortion, in hospital care (1‐2days) ]
Measured in visual analog scale (VAS, 0‐100mm). VAS is lower."
Secondary outcomes: "Patient satisfaction is higher [ Time Frame: just after the abortion and 2‐3 weeks after in follow‐up visit ]
Measured in visual analog scale (VAS, 0‐100mm), VAS is higher."
Notes