Pain and Medical Abortion Among Teenaged Women Compared to Adult Women
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      In this two-parted study the need and sufficiency of analgesics and experienced pain is
      compared between teen-aged and adult women undergoing medical termination of pregnancy
      (MToP)in early pregnancy (under 9weeks of gestation). During MToP at pregnancy weeks 9-20
      on-demand administration of opiates and patient-controlled analgesia (PCA) are compared in
      randomized clinical trial.
    

Detailed description: 
      Adequate pain control is crucial in medical abortion. Experience of painful and traumatic
      abortion can affect patients future plans on pregnancy and childbirth. Study's purpose is to
      investigate only pain experience and pain management. Otherwise the care of abortion is
      according to present Finnish national guideline.

      Study's goal is to evaluate experienced pain and the need and adequacy of analgesics and to
      obtain more efficient analgesics during MToP. In addition investigators hope to recognize
      predicting factors of severe pain.

      Study is done in cooperation with Helsinki university and Helsinki university central
      hospital and is accomplished in Womens hospital and Kätilöopisto hospital in which care of
      abortions is centralized in HUS area.

      Altogether 340 women, who are primigravid, aged between 15-19 or 25-35 years and tolerate
      used analgesics, are recruited in the study. MToP is done with the combination on
      mifepristone 200mg and misoprostol 800ug according to Finnish national guidelines. Baseline
      analgesics are Ibuprofein 600mg ja Paracetamol 1000mg, both three times a day and first dose
      is taken simultaneously with Misoprostol.

      First part is a prospective study in which we compare pain experience and sufficiency of
      analgesics during MToP in early pregnancy (under 9 weeks of pregnancy). Pain is measured by
      VAS, which is reported in a diary every time analgesics are needed.

      Second part is a controlled randomized study with PCA and on-demand pain management during
      medical termination of pregnancy with gestational age of 9 to 20 weeks. Every teen-aged woman
      has two adult controls.

      Against severe pain patients get Opiates (oxycodone). In intervention group patients get PCA
      with Oxycodon dose of 3.0 mg maximal four times in an hour. In control group Oxycodon is
      administrated on demand po, im or iv depending on the intensity of pain. Pain is measured by
      VAS from the onset of pain and repeated every 30 minutes until fetal expulsion.
    

Intervention name(s): Oxynorm on-demand; Oxynorm via PCA
Intervention type(s): Drug; Drug
Intervention description(s): 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 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 mg at time between 2.0-4.0 mg and maximal number of doses can be up to 5.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Abortion, Drug-Induced; Pain Management