PainPhase 4NCT02678897
Pain and Medical Abortion Among Teenaged Women Compared to Adult Women
A Phase 4 study testing Oxynorm on-demand and Oxynorm via PCA in people with Pain, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 to 35 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Oxynorm on-demand and Oxynorm via PCA
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 2 sitesFinland
- Study dates
- Mar 2016to 31 Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Central hospital, Kätilöopistohospital
Helsinki, HUS, 00029
Helsinki University central hospital, Naistenklinikka
Helsinki, HUS, 00029
About this study
Official title: Pain and Medical Abortion - Predicting Factors of Pain and Optimal Pain Management Among Teenaged Women Compared to Adult Women
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Oxynorm on-demand, Oxynorm via PCA
- Keywords
- Abortion, Drug-Induced, Pain Management
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxynorm on-demandDrug
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.
Oxynorm via PCADrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pain management in early pregnancy MTOP | No intervention | Patients in early pregnancy (pregnancy weeks <9weeks) undergoing medical termination of pregnancy gets Ibuprofen (tbl 600mg 3 times a day) and Paracetamol (tbl 1000mg 3 times a day). |
| Patient controlled analgesia (PCA) | Experimental | Pregnancy weeks 9-20. All patients get baselineanalgesics: Ibuprofein 600mg and Paracetamol 1000mg both x3 a day.
Patients get pain medication (Oxynorm) via PCA Receives: Drug: Oxynorm via PCA |
| Oxynorm on-demand | Active comparator | Pregnancy weeks 9-20. All patients get baselineanalgesics: Ibuprofein 600mg and Paracetamol 1000mg both x3 a day.
Patients get extra pain medication (Oxynorm) on-demad from the nurse. Receives: Drug: Oxynorm on-demand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients are less painful using patient controlled analgesia (PCA)
Measured in visual analog scale (VAS, 0-100mm). VAS is lower.
Measured: During drug-induced abortion, in hospital care (1-2days)
Secondary outcomes (1)
Patient satisfaction is higher
Measured in visual analog scale (VAS, 0-100mm), VAS is higher.
Measured: just after the abortion and 2-3 weeks after in follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Venla Kemppainen, Helsinki University Central Hospital
- Investigators
- Oskari Heikinheimo, Professor, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678897
- Sponsor's protocol ID
- HUS277/03/2015
- Other IDs
- 2015-003760-36, 2015-005657-12, 2015
- Status last verified
- Sep 2018
- First submitted
- 16 Dec 2015
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Medical Abortion - Predicting Factors of Pain and Optimal Pain Management Among Teenaged Women Compared to Adult Women
- ClinicalTrials.gov ID
- NCT02678897
- Acronym / sponsor ID
- HUS277/03/2015
- Conditions
- Pain
- Keywords
- Abortion, Drug-Induced, Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- Mar 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pain management in early pregnancy MTOP | No intervention | –Patients in early pregnancy (pregnancy weeks <9weeks) undergoing medical termination of pregnancy gets Ibuprofen (tbl 600mg 3 times a day) and Paracetamol (tbl 1000mg 3 times a day). |
| Patient controlled analgesia (PCA) | Experimental | Drug: Oxynorm via PCAPregnancy weeks 9-20. All patients get baselineanalgesics: Ibuprofein 600mg and Paracetamol 1000mg both x3 a day. Patients get pain medication (Oxynorm) via PCA |
| Oxynorm on-demand | Active comparator | Drug: Oxynorm on-demandPregnancy weeks 9-20. All patients get baselineanalgesics: Ibuprofein 600mg and Paracetamol 1000mg both x3 a day. Patients get extra pain medication (Oxynorm) on-demad from the nurse. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
- Abortion is done based on foetal abnormality or threat of patient's own health
- Minor patient does not want to inform guardian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxynorm on-demandWe 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. | Drug | Oxynorm on-demand |
| Oxynorm via PCAWe 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. | Drug | Patient controlled analgesia (PCA) |
Primary outcome
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.
1 secondary outcome
Patient satisfaction is higher
Time frame: just after the abortion and 2-3 weeks after in follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oskari Heikinheimo, Professor study director
Helsinki University Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxynorm on-demand and Oxynorm via PCA in people with Pain, run by Helsinki University Central Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients are less painful using patient controlled analgesia (PCA) (time frame: During drug-induced abortion, in hospital care (1-2days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.