EUCTR2015‐003760‐36‐FI.
Methods | NR |
Participants | "INCLUSION CRITERIA: Patients choosing medical abortion, are first time pregnant, are aged between 15 to 19 years and 25 to 35 years. Attending the study is voluntary Are the trial subjects under 18? yes" |
Interventions | "INTERVENTION: Trade Name: oxynorm Product Name: oxynorm Pharmaceutical Form: Solution for injection/infusion Trade Name: oxanest Product Name: Oxanest Pharmaceutical Form: Solution for injection/infusion Trade Name: Oxynorm Product Name: oxynorm Pharmaceutical Form: Oral suspension" |
Outcomes | "PRIMARY OUTCOME: Main Objective: Adequate analgesia is crucial in patients undergoing medical abortion. We compare in controlled randomized trial pain management via PCA (patient controller analgesia) to our standard pain management in patients undergoing medical termination of pregnancy with gestational age over 9 weeks. In short we compare different administration routes of oxycodon; We hope to recognize those patients who benefit from more intensive pain management and to create guideline so that all patients receive adequate analgesia in the future. Primary end point(s): Pain management via PCA is more effective (pain VAS [visual analogue scale] is lower) and patient's satisfaction is higher; Teen‐aged women profit more on effective pain management than their adult controls. Secondary Objective: Experience of painful and traumatic abortion may affect patients' future plans for pregnancies and childbirth. In addition this may lead patient to choose surgical abortion in case of reapportion, which exposes patient to operative risks. Timepoint(s) of evaluation of this end point: Collecting data takes about 1,5‐2 years and is done by the end of the year 2017" "SECONDARY OUTCOME: Secondary end point(s): Predicting factors of pain are patient's young age any longer duration of pregnancy. Timepoint(s) of evaluation of this end point: Data is collected and ready to be evaluated in the end of the year 2017" |
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