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)"
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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)
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.
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.
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)
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.
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."
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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 |
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