Analgesia controlada por paciente con remifentanil vs bloqueo peridural en analgesia obstétrica. Estudio multicéntrico randomizado
Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial.
Freeman LM, Bloemenkamp KW, Franssen MT, Papatsonis DN, Hajenius PJ, Hollmann MW, Woiski MD, Porath M, van den Berg HJ, van Beek E,Borchert OW, Schuitemaker N, Sikkema JM, Kuipers AH, Logtenberg SL, van der Salm PC, Oude Rengerink K, Lopriore E, van den Akker-van Marle ME, le Cessie S, van Lith JM, Struys MM, Mol BW, Dahan A, Middeldorp JM.
BMJ. 2015 Feb 23;350:h846. doi: 10.1136/bmj.h846.
Abstract
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 pain relief was 30.9 in the remifentanilgroup versus 33.7 in the epidural analgesia group (mean difference -2.8, 95% confidence interval -6.9 to 1.3). For who actually received pain relief the area under the curve for satisfaction with pain relief after the start of pain relief was 25.6 in the remifentanil group versus 36.1 in the epidural analgesia group (mean difference -10.4, -13.9 to -7.0). The rate of caesarean section was 15% in both groups. Oxygen saturation was significantly lower (SpO2 <92%) in women who used remifentanil (relative risk 1.5, 1.4 to 1.7). Maternal and neonatal outcomes were comparable between both groups. CONCLUSION: In women in labour, patient controlled analgesia with remifentanil is not equivalent to epidural analgesia with respect to scores on satisfaction with pain relief. Satisfaction with pain relief was significantly higher in women who were allocated to and received epidural analgesia.
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Remifentanil intravenoso vs ropivacaína epidural con sufentanil para analgesia de parto. Estudio retrospectivo
Intravenous remifentanil versus epidural ropivacaine with sufentanil for labour analgesia: a retrospective study.
Lin R, Tao Y, Yu Y, Xu Z, Su J, Liu Z.
PLoS One. 2014 Nov 11;9(11):e112283. doi: 10.1371/journal.pone.0112283. eCollection 2014.
Abstract
Remifentanil with appropriate pharmacological properties seems to be an ideal alternative to epidural analgesia during labour. A retrospective cohort study was undertaken to assess the efficacy and safety of remifentanil intravenous patient-controlled analgesia (IVPCA) compared with epidural analgesia. Medical records of 370 primiparas who received remifentanil IVPCA or epidural analgesia were reviewed. Pain and sedation scores, overall satisfaction, the extent of pain control, maternal side effects and neonatal outcome as primary observational indicators were collected. There was a significant decline of pain scores in both groups. Pain reduction was greater in the epidural group throughout the whole study period (0 ∼ 180 min) (P < 0.0001), and pain scores in the remifentanil group showed an increasing trend one hour later. The remifentanil group had a lower SpO2 (P < 0.0001) and a higher sedation score (P < 0.0001) within 30 min after treatment. The epidural group had a higher overall satisfaction score (3.8 ± 0.4 vs. 3.7 ± 0.6, P = 0.007) and pain relief score (2.9 ± 0.3 vs. 2.8 ± 0.4, P < 0.0001) compared with the remifentanil group. There was no significant difference on side effects between the two groups, except that a higher rate of dizziness (1% vs. 21.8%, P < 0.0001) was observed duringremifentanil analgesia. And logistic regression analysis demonstrated that nausea, vomiting were associated with oxytocin usage and instrumental delivery, and dizziness was associated to the type and duration of analgesia. Neonatal outcomes such as Apgar scores and umbilical-cord blood gas analysis were within the normal range, but umbilical pH and base excess of neonatus in the remifentanil group were significantly lower. RemifentanilIVPCA provides poorer efficacy on labor analgesia than epidural analgesia, with more sedation on parturients and a trend of newborn acidosis. Despite these adverse effects, remifentanil IVPCA can still be an alternative option for labor analgesia under the condition of one-to-one bedside care, continuous monitoring, oxygen supply and preparation for neonatal resuscitation.
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Comparación de remifentanil-etonox vs etononox en analgesia de parto
Comparison of remifentanil: Entonox with Entonox alone in labor analgesia.
Varposhti MR, Ahmadi N, Masoodifar M, Shahshahan Z, Tabatabaie MH.
Adv Biomed Res. 2013 Nov 30;2:87. doi: 10.4103/2277-9175.122511. eCollection 2013.
Abstract
BACKGROUND: We designed a study to evaluate the effectiveness of continuous low dose infusion of remifentanil adding to self-administration of entonox administered for pain relief during the active phase of first stage of labor. MATERIALS AND METHODS: Thirty healthy term pregnant women recruited in our randomized double-blind, cross over study. They received the study medicines during two 30-min periods with a 15-min wash-out sequence after each period. Fifteen parturient used remifentanil as a single bolus dose followed by constant low dose infusion and self-administration of entonox (group R) during the first period and entonox and saline (group P) during the second period, while the remainder of the parturient used the drugs in a reverse order. Pain and Ramsay score, maternal and fetal hemodynamic, and ventilation were assessed during each intervention. RESULTS: In this study, mean pain severity scores were 8 ± 0.9 before and 5.4 ± 1.7 after intervention in group P, and 7.8 ± 0.1, 3.5 ± 1.3 in group R, respectively. Mean pain severity difference was 2.6 ± 1.5 in group P, while 4.3 ± 1.5 in group R; so, use of entonox and remifentanil can decreaselabor pain two times more in comparison with entonox/placebo (normal saline). However, hemodynamic and ventilation parameter inremifentanil/entonox period were same as in entonox/placebo period. No statistical differences were seen in mean Ramsay score between group R and P. There was no episode of maternal bradycardia, hypotension, or hypoxemia. CONCLUSION: Not only adding low dose infusion of remifentanil to self-administration of entonox was notable in labor pain reduction, it did n't make more parturient and neonatal side-effects.
KEYWORDS: Entonox; labor pain; remifentanil
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