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Remifentanil is a ultra short-acting synthetic opioid. It is rapidly metabolized by non-specific blood and tissue esterases. We wanted to investigate the efficacy and safety of remifentanil used as analgesia during labour. Intravenous patient controlled analgesia (ivpca) were used to administer remifentanil. Doses used were 0,15-1,05 mikrogr/kg, with a lock-out time of 2 minutes. 41 women were included in the study. Blood-pressure, heartrate, SaO2, respiration rate and sedation were recorded every 15.minute. Fetal heart rate was recorded for the whole periode of treatment (CTG, STAN). Vaginal contraction pain were assessed by the parturients every 15.minute using a Visual Analogue Scale (VAS). Midwives also recorded their impression of the parturients pain. The parturients level of sedation were recorded by anesthesiologist and midwife every 15.minute. Apgar scores were registered at 1, 5 and 10 min after delivery. Umbilical cord blood analysis regarding blood gases and concentration of remifentanil were performed. After delivery, both mother and midwife evaluated efficacy and safety; Global satisfaction score, if the remifentanil doses were sufficient, nausea, vomiting, level of sedation and dizziness.
Primary and secondary outcome measures presented under "results"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil IVPCA | Active Comparator | Bolus dose steps of 0.15 microgr/kg, with a 2-min lock-out time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | Intravenous patient controlled analgesia (ivpca) during labour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain) | Continuous Visual Analogue Scale 0 - 100 millimeters (0=no pain, 100=worst imaginable pain) Registration of pain scores before start and every 15.minute during treatment with remifentanil. Result given is the maximal change in pain score (mean) compared to the baseline value at the given timepoints. | From start with remifentanil treatment until delivery, up to 8 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Patient satisfaction with remifentanil pain relief by use of questionnaire answered within 24 hours after delivery. Evalutated by a 5-point scale; 1-very satisfied.......5-very dissatisfied. | From start of remifentanil treatment until delivery |
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Inclusion Criteria:
Healthy women (ASA I-II), in active labour, one fetus with no suspected pathology, expecting normal childbirth, informed consent.
Exclusion Criteria:
Failure to obtain informed consent, received opioids within last 8 hours before study start, serious side-effects mother and abnormal fetal heart rate.
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| Name | Affiliation | Role |
|---|---|---|
| Jan H. Rosland, Professor | part time | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sorlandet sykehus HF | Kristiansand | Vest-Agder | N-4623 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11517125 | Background | Blair JM, Hill DA, Fee JP. Patient-controlled analgesia for labour using remifentanil: a feasibility study. Br J Anaesth. 2001 Sep;87(3):415-20. doi: 10.1093/bja/87.3.415. |
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Recruited at arrival to the Labour department
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| ID | Title | Description |
|---|---|---|
| FG000 | Effect and Side Effects of Remifentanil | Analgesic efficacy and side offects of remifentanil during labour and delivery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Women in Labour Given Remifentanil Analgesia | Administration of remifentanil analgesia startet with cervical dilatation > 4 cm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain) | Continuous Visual Analogue Scale 0 - 100 millimeters (0=no pain, 100=worst imaginable pain) Registration of pain scores before start and every 15.minute during treatment with remifentanil. Result given is the maximal change in pain score (mean) compared to the baseline value at the given timepoints. | Per protocol | Posted | Mean | Standard Deviation | millimeters | From start with remifentanil treatment until delivery, up to 8 hours. |
|
|
From start of remifentanil analgesia until delivery
Continuous monitoring of oxygen saturation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maternal Oxygen Desaturation | Oxygen saturation lower than 92% during labour and delivery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oxygen saturation lower than 92% | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Oxygen saturation lower than 92% during labour and delivery, administration of supplemental oxygen |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Maternal sedation | Nervous system disorders | Systematic Assessment | The participants evaluation of sedation level during remifentanil treatment by use of questionnaire within 24 hours after delivery (1=no sedation, 5=very sedated). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tor Tveit | Sorlandet Hospital HF | +4738073608 | tor.tveit@sshf.no |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Patient Satisfaction | Patient satisfaction with remifentanil pain relief by use of questionnaire answered within 24 hours after delivery. Evalutated by a 5-point scale; 1-very satisfied.......5-very dissatisfied. | Posted | Number | Participants | From start of remifentanil treatment until delivery |
|
|
|
| 11 |
| 41 |
| 22 |
| 41 |
|
|
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| D001519 | Behavior |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |