Pain Clinical Trial
Official title:
Pain and Medical Abortion - Predicting Factors of Pain and Optimal Pain Management Among Teenaged Women Compared to Adult Women
Verified date | September 2018 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 242 |
Est. completion date | August 31, 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years to 35 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University Central hospital, Kätilöopistohospital | Helsinki | HUS |
Finland | Helsinki University central hospital, Naistenklinikka | Helsinki | HUS |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital | Helsinki University |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Teen-aged women experience more severe pain than their adult comparators. | Measured: Age, visual analogue scale (pain-VAS) is higher during medical abortion. | during drug-induced abortion | |
Other | Patients with history of dysmenorrhea or anxiety experience more severe pain 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 | During drug-induced abortion | |
Primary | Patients are less painful using patient controlled analgesia (PCA) | Measured in visual analog scale (VAS, 0-100mm). VAS is lower. | During drug-induced abortion, in hospital care (1-2days) | |
Secondary | Patient satisfaction is higher | Measured in visual analog scale (VAS, 0-100mm), VAS is higher. | just after the abortion and 2-3 weeks after in follow-up visit |
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