Trending Articles
-
Randomized Controlled Trial Multicenter Study Clinical Trial
A factorial trial of six interventions for the prevention of postoperative nausea and vomiting.
Ondansetron, dexamethasone, droperidol and total intravenous anesthesia (TIVA) all have a roughly similar, productive effect to reduce postoperative nausea and vomiting (PONV) by about one third.
pearl -
Randomized Controlled Trial Multicenter Study Comparative Study
Clonidine in patients undergoing noncardiac surgery.
Perioperative clonidine administration does not reduce mortality or myocardial infraction, but does increase the risk of hypotension and non-fatal cardiac arrest.
pearl -
Multicenter Study Clinical Trial
Peri-partum reference ranges for ROTEM(R) thromboelastometry.
Post-partum haemorrhage (PPH) causes rapidly developing deficiencies in clotting factors and contributes to substantial maternal morbidity and mortality. Rotational thromboelastometry (ROTEM(®)) is increasingly used as a point of care coagulation monitoring device in patients with massive haemorrhage; however, there are limited data on reference ranges in the peri-partum period. These are required due to the haemostatic changes in pregnancy. ⋯ Reference values for ROTEM(®) parameters are reported. The previously published correlation between FIBTEM parameters and plasma fibrinogen levels by the Clauss method is confirmed. Further research is needed to define threshold values for haemostatic therapy in the course of PPH. Clinical trial registration NTR 2515 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2515).
-
Randomized Controlled Trial Multicenter Study Comparative Study
Intravenous remifentanil patient-controlled analgesia versus intramuscular pethidine for pain relief in labour (RESPITE): an open-label, multicentre, randomised controlled trial.
What did they do?
Wilson et al randomized 401 laboring women across multiple centers to either remifentanil PCA or pethidine/meperidine IM, then compared the progression of these women to labour epidural.
On the surface... this might appear disingenuous, as it compares remifentanil PCA to widely-shown-to-be-ineffective parenteral pethidine – rather than to the gold standard labour epidural. But it's also a study of how the technique might practically be used in the real world.
What they found
Women with remifentanil PCA progressed half as often to require epidural analgesia than those receiving pethidine (19% vs 41%).
Though it's one of the secondary findings that is most interesting: the remifentanil group were less likely to need instrumental delivery (15% vs 26%).
But don't get carried away
Despite the demonstrated superiority of remi PCA to pethidine, the technique is not without it's issues:
- Safety concerns regarding respiratory depression cannot be ignored, and because managing this relies upon staff vigilance, increased PCA use may conversely lead to a normalisation of risk and institutional complacency, rather than safety improvement.
- Analgesia is still inferior to epidural, even if maternal satisfaction is comparable.
- Technique acceptability might not be as good in communities with high pre-existing epidural use.
And finally... why are we so eager to do away with the labour epidural? Serious complications are very uncommon to rare, the technique is widely acceptable to women, and it is more effective than any other modality.
Is this change driven by the needs of pregnant women, or the health system's limited resources?
summary -
Randomized Controlled Trial Multicenter Study
Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial.
Why is this a landmark trial?
Three reasons:
- Clinical significance of the findings: reducing maternal mortality.
- Relevance to much of world's population, in particular to low resource settings where post-partum haemorrhage (PPH) is disproportionately burdensome.
- Quality – a massive, double-blinded randomised controlled trial.
So, what did they do?
They randomised 20,060 women with PPH to receive either 1g of tranexamic acid (100mg/min slow IV) or placebo, across 21 countries and 193 hospitals. Although only 569 (2.8%) patients were from a high resource country (UK).
What did they find?
Mortality due to haemorrhage was reduced by almost 20% (RR 0.81, NNT 267) after receiving tranexamic acid (TXA), and by 30% (RR 0.69) when given within 3 hours of birth.
Hysterectomies were not reduced by TXA use. There was no increased risk of thromboembolic events.
Be smart
While on the surface this suggests we should move to routine use of TXA in managing all PPH, the risk of PPH-death in most high resource countries is relatively low. 99% of all PPH deaths are in low resource countries.
In the WOMAN trial the risk of death in the placebo group was 1.9%. In contrast the latest maternal mortality data from MBRACE-UK (2014-16) reports 0.78 haemorrhage-deaths per 100,000 maternities, which using a conservative 5% PPH incidence (depending on definition), yields a PPH-mortality risk of 0.016% – 100x less than the study population.
Thus in a high resource setting the TXA NNT to avoiding one maternal death is generously at least 20,000 PPH cases.
In high resource settings, TXA use should be considered second-line therapy in managing severe PPH when other measures are inadequate. In low resource settings where maternal PPH mortality Is high, TXA reduces maternal mortality and should be routinely used.
Context is everything.
summary