Adverse Effects, Labour Pain, Satisfaction
Conditions
Keywords
Remifentanil, parenteral opioids, obstetric analgesia, IVPCA
Brief summary
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.
Detailed description
Primary and secondary outcome measures presented under results
Interventions
DRUGRemifentanil
Intravenous patient controlled analgesia (ivpca) during labour
Sponsors
Sorlandet Hospital HF
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain) | From start with remifentanil treatment until delivery, up to 8 hours. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | From start of remifentanil treatment until delivery | 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. |
Countries
Norway
Participant flow
Recruitment details
Recruited at arrival to the Labour department
Participants by arm
| Arm | Count |
|---|---|
| Women in Labour Given Remifentanil Analgesia Administration of remifentanil analgesia startet with cervical dilatation \> 4 cm | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | Women in Labour Given Remifentanil Analgesia |
|---|---|
| Age, Continuous | 27 years |
| Region of Enrollment Norway | 41 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 41 |
| serious Total, serious adverse events | 11 / 41 |
Outcome results
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.
Time frame: From start with remifentanil treatment until delivery, up to 8 hours.
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remifentanil | Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain) | 47 millimeters | Standard Deviation 20.2 |
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.
Time frame: From start of remifentanil treatment until delivery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remifentanil | Patient Satisfaction | 37 Participants |