Remifentanil as Intravenous Patient-controlled Analgesia (IVPCA) During Labour
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StatusConcluído
Patrocinadores
Sorlandet Hospital HF
ENSAIO CLÍNICO: NCT00202722
BioSeek: nct00202722
Palavras-chave
Resumo
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.
Descrição
Primary and secondary outcome measures presented under "results"
datas
| Última verificação: | 04/30/2014 |
| Enviado pela primeira vez: | 09/11/2005 |
| Inscrição estimada enviada: | 09/12/2005 |
| Postado pela primeira vez: | 09/19/2005 |
| Última atualização enviada: | 05/21/2014 |
| Última atualização postada: | 06/22/2014 |
| Data dos primeiros resultados enviados: | 03/15/2010 |
| Data dos primeiros resultados de QC enviados: | 05/21/2014 |
| Data dos primeiros resultados postados: | 06/22/2014 |
| Data real de início do estudo: | 12/31/2003 |
| Data Estimada de Conclusão Primária: | 06/30/2007 |
| Data Estimada de Conclusão do Estudo: | 07/31/2007 |
Condição ou doença
Labour Pain
Satisfaction
Adverse Effects
Intervenção / tratamento
Drug: Remifentanil IVPCA
Fase
Fase 4
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Active Comparator: Remifentanil IVPCA Bolus dose steps of 0.15 microgr/kg, with a 2-min lock-out time | Drug: Remifentanil IVPCA Intravenous patient controlled analgesia (ivpca) during labour |
Critério de eleição
| Sexos elegíveis para estudo | Female |
| Aceita Voluntários Saudáveis | sim |
| Critério | 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. |
Resultado
Medidas de Resultado Primário
1. 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.
Medidas de Resultado Secundário
1. 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.
