Pain
Conditions
Keywords
Abortion, Drug-Induced, Pain Management
Brief 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.
Interventions
DRUGOxynorm 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. 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 mg at time between 2.0-4.0 mg and maximal number of doses can be up to 5.
DRUGOxynorm 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 mg at time between 2.0-4.0 mg and maximal number of doses can be up to 5.
Sponsors
University of Helsinki
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients are less painful using patient controlled analgesia (PCA) | During drug-induced abortion, in hospital care (1-2days) | Measured in visual analog scale (VAS, 0-100mm). VAS is lower. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction is higher | just after the abortion and 2-3 weeks after in follow-up visit | Measured in visual analog scale (VAS, 0-100mm), VAS is higher. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Teen-aged women experience more severe pain than their adult comparators. | during drug-induced abortion | Measured: Age, visual analogue scale (pain-VAS) is higher during medical abortion. |
| Patients with history of dysmenorrhea or anxiety experience more severe pain during drug-induced abortion. | During drug-induced abortion | VAS-scale asked about pain during menstrual bleeding, Anxiety questionnaire (GHQ12, anxiety level is higrher) and Visual analogue scale (VAS) of pain during medical abortion is higher |
Countries
Finland
Outcome results
None listed