Patient controlled analgesia with remifentanil versus epidural analgesia in labour: Randomised multicentre equivalence trial

Objective To determine women’s satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Design Multicentre randomised controlled equivalence trial. Setting 15 hospitals in the Netherlands. Participants Women with an intermediate to high obstetric risk with an intention to deliver vaginally. To exclude a clinically relevant difference in satisfaction with pain relief of more than 10%, we needed to include 1136 women. Because of missing values for satisfaction this number was increased to 1400 before any analysis. We used... Mehr ...

Verfasser: Freeman, L.
Bloemenkamp, K.
Franssen, M.
Papatsonis, D.
Hajenius, P.
Hollmann, M.
Woiski, M.
Porath, M.
Van Den Berg, H.
Van Beek, E.
Borchert, O.
Schuitemaker, N.
Sikkema, J.
Kuipers, A.
Logtenberg, S.
Van Der Salm, P.
Rengerink, K.
Lopriore, E.
Van Den Akker-van Marle, M.
Le Cessie, S.
Dokumenttyp: Journal article
Erscheinungsdatum: 2015
Verlag/Hrsg.: BMJ Publishing Group Ltd
Schlagwörter: Humans / Piperidines / Analgesics / Opioid / Pain Measurement / Analgesia / Epidural / Obstetrical / Patient-Controlled / Area Under Curve / Cross-Over Studies / Therapeutic Equivalency / Pregnancy / Adult / Patient Satisfaction / Netherlands / Female / Young Adult / Pain Management
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-26827839
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : http://hdl.handle.net/2440/102203

Objective To determine women’s satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Design Multicentre randomised controlled equivalence trial. Setting 15 hospitals in the Netherlands. Participants Women with an intermediate to high obstetric risk with an intention to deliver vaginally. To exclude a clinically relevant difference in satisfaction with pain relief of more than 10%, we needed to include 1136 women. Because of missing values for satisfaction this number was increased to 1400 before any analysis. We used multiple imputation to correct for missing data. Intervention Before the onset of active labour consenting women were randomised to a pain relief strategy with patient controlled remifentanil or epidural analgesia if they requested pain relief during labour. Main outcome measures Primary outcome was satisfaction with pain relief, measured hourly on a visual analogue scale and expressed as area under the curve (AUC), thus providing a time weighted measure of total satisfaction with pain relief. A higher AUC represents higher satisfaction with pain relief. Secondary outcomes were pain intensity scores, mode of delivery, and maternal and neonatal outcomes. Analysis was done by intention to treat. The study was defined as an equivalence study for the primary outcome. Results 1414 women were randomised, of whom 709 were allocated to patient controlled remifentanil and 705 to epidural analgesia. Baseline characteristics were comparable. Pain relief was ultimately used in 65% (447/687) in the remifentanil group and 52% (347/671) in the epidural analgesia group (relative risk 1.32, 95% confidence interval 1.18 to 1.48). Cross over occurred in 7% (45/687) and 8% (51/671) of women, respectively. Of women primarily treated with remifentanil, 13% (53/402) converted to epidural analgesia, while in women primarily treated with epidural analgesia 1% (3/296) converted to remifentanil. The area under the curve for total satisfaction with ...