Warning

The content you’re about to read or listen to is at least two years old, which means evidence and guidelines may have changed since it was originally published. This content item won’t be edited but there will be a newer version published if warranted. Check the new publications and curriculum map for updates

 

Authors: Becky Maxwell, Craig Davidson, Andy Neill, Chris Connolly / Code: NeuC12, PC1, PC4, SLO1, SLO3, SLO6 / Published: 07/09/2017

Paper 1

Clinical Question to be answered

  • Is propofol or ketofol (1:1 ketamine/propofol mix) better for procedural sedation in adults in an ED?

Title of paper

  • Propofol or Ketofol for Procedural Sedation and Analgesia in Emergency Medicine The POKER Study: A Randomized Double-Blind Clinical Trial

Journal and year

  • Annals of Emergency Medicine 2016

Lead Author

  • Ferguson 

Name of contributor

  • Chris Connolly

Patients studied

  • Adult Patients who required deep sedation for a painful procedure

Intervention

  • Ketofol: single syringe mix of 10mls (100mg) and 10mls ketamine (100mg) total 20mls opaque white liquid titrated to effect

Comparison

  • 20mls of propofol (200mg) titrated to effect

Primary outcome

  • Primary outcome was an occurrence of a respiratory adverse event 

Summary of results

  • No significant difference in composite primary outcome. 
  • Secondary outcome measure showed no difference in patient satisfaction despite higher emergence phenomena in the ketofol arm. 
  • Increased hypotension rates in the propofol arm, but of doubtful clinical effect. 

Strengths

  • Pragmatic approach – IV opiates allowed in line with usual practice before randomisation/allocation.
  • Sedationist guided sedation end point
  • Randomisation was done by computer program
  • Blinding of treating clinician was attempted by having someone not related to the procedure draw up the drugs in a separate area of the dept. 
  • Patient was blinded to study medication.
  • Sample size calculation was done.

Weaknesses

  • Composite primary outcome 
  • Power to detect a change or 10% in an event that is unlikely to occur 10% of the time.
  • Initial bolus dose seems low i wonder…
  • Inclusion was only for ‘deep sedation’ required – this is against the pragmatic approach demonstrated in parts of the methods.

Clinical Bottom Line

  • There is no significant difference in respiratory adverse event rates when using ketofol or propofol for sedation in adults in an ED.

Any other FOAM sites where you found it or who have discussed it already so that we can be sure to give kudos

  • REBEL EM
  • http://www.totalem.org/emergency-professionals/podcast-7-ketofol-and-the-poker-trial

Paper 2

Clinical Question to be answered

  • For reduction of anterior shoulder dislocation is an injection of intra-articular lidocaine comparable in terms of safety and efficacy to intraveous procedural sedation?

Title of paper

  • Intra-articular lidocaine versus intravenous sedative and analgesic forreduction of anterior shoulder dislocation

Journal and year

  • 2016 Turkish Journal of Emergency Medicine

Lead Author

  • Kashani

Name of contributor

  • Becky Maxwell

Patients studied

  • Adults (18-40 yo) who had an anterior shoulder dislocation who attended one of two EDs 

Intervention

  • Intra-articular injection Lidocaine 20mls 1%using landmark technique – reduction was attempted 15 minutes after this intervention

Comparison

  • Procedural sedation using midazolam (0.05mg/kg) and fentanyl (1mcg/kg) as their sedation agents

Primary outcome

  • Multiple outcomes – we have discussed issues with not have one outcome before in this podcasts. 
    • Patient satisfaction (using a 5-choice ques-tionnaire), 
    • pain measurement (using a visual analog scale rangingfrom 0 to 10 points), 
    • recovery time, and 
    • side effects during and after reduction were assessed and compared between the two groups. 

Summary of results

  • 104 patients with acute anterior shoulder dislocation
  • mean age of 28.75 ( all relatively young!)
  • No significant difference was seen in average pain intensity before and after the reduction in the 2 groups.
  • Mean pain intensity during reduction in sedation group was significantly higher than intra-articular group
  • Patient satisfaction in sedation group was significantly higher than intra-articular group (odd considering the above result about pain!). Look at table 3 – 9 patients were completely dissatisfied with the intra-articular injection!
  • Success rate at reduction was similar in both groups
  • Unsuprisingly time to discharge was significantly shorter in the Intra-articular group!
  • Adverse events were higher in the sedation group: there were 0 adverse events with the injections, versus 11% apnea and 10% hypoxia with the sedation. . 

Strengths

  • Prospective randomised study that attempts to answer a question that important to us clinically in the ED. Groups were matched.

Weaknesses

  • Choice of sedative midazolam and fentanyl – most people use something else these days. 
  • Certainly i reach for the propofol and fentanyl in this group. Midazolam ‘dirty drug’ I tend to try and avoid using these days. 
  • Choice of rigid dosing for sedation rather than use a sedation scale to achieve the level of sedation they want – could this account for the pain scores in the sedation group – perhaps some people weren’t as well sedated as they should have been. Midazolam should have an amnesic effect therefore why ask the pain score at all during procedure?? Is this reliable???
  • Adverse reactions really high – 11% people with hypoxia and 10% with apnoea in sedation group – is this due to choice of sedative??

Clinical Bottom Line

  • Going to take the clinical bottom line from two viewpoints:
    1. as a clinician – I don’t sedate too many shoulders anyway so perhaps the introduction of an intra- articular injection in my weaponry for those patients I’m not sedating would be worth a go…..
    2. as the patient – I choose this paper as alongside some of my colleagues we decided to do a gentle jog around a muddy obstacle course this weekend. Simon was consultant on call for our ED and I said to him if I disclosed my shoulder and came in that I wanted the “good drugs”. Simon suggested an IA injection. As it stands as a patient I still want the good drugs!

Any other FOAM sites where you found it or who have discussed it already so that we can be sure to give kudos

Ultrasound diagnosis of dislocation and injection

www.youtube.com/watch?v=siGzMvakY8s

Landmark guided injection

https://www.youtube.com/watch?v=pIBJORPktDY

Paper 3

Clinical Question to be answered

  • In patients with acute intracerebral haemorrhage and who are hypertensive, does rapid lowering of systolic blood pressure compared to standard therapy improve patient outcomes?

Title of paper

  • Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage

Journal and year

  • New England Journal of Medicine

Lead Author

  • Adnan I. Qureshi

Name of contributor

  • Craig Davidson

Patients studied

  • Patient >18 years old, GCS of greater than 4, presenting with intraparenchymal hematoma of less than 60 cm3 on initial CT.
  • At least one reading of systolic blood pressure of 180 mm Hg or more between symptom onset and the initiation of intravenous antihypertensive treatment was required for eligibility.
  • Antihypertensive treatment had to be started within 4.5 hours from symptom onset. (initially 3 but extended)

Intervention

  • SBP treatment target of less than 140 in the first 2 hours, for 24 hours. 

Comparison

  • SBP treatment target of less than 180 in the first 2 hours for 24 hours. 

Primary outcome

  • Death or Disability (mRS 4+) at 3 months. 
  • Plus secondary Outcomes: 
    • EQ-5D scores at 3 months (QoL)
    • VAS QoL at 3 months
    • Proportion of patients with expansion of 33% or more in volume of haematoma on 24 hour scan compared to baseline scan
    • Safety outcomes (fall in GCS by 2 or increase of NIH Stroke Score by 4)
    • Incidence of serious adverse events within 72 hours and 3 months.

Summary of results

  • No difference in primary outcome or any secondary outcomes apart from: Higher serious adverse events at 3 months in the intervention group. 

Strengths

  • Multi-centre, randomised, 
  • assessors blinded to treatment. 
  • Fairly pragmatic
  • Clinically meaningful and patient relevant outcomes

Weaknesses

  • 8500 patients screened and 1000 randomised. Unclear why so many exclusions from the paper – ? selection bias
  • Under-powered – power calculations based on event rate of 60%, actual observed event rate in study of 38%. A lower event means that you have to test a bigger population to detect a significant difference. Its therefore possible examining a bigger population may detect a difference. 
  • More patients had treatment failure in intensive group compared to standard group (approx. 13% vs 1%) – although that might be quite pragmatic.

Clinical Bottom Line

  • No benefit. Keep it simple. Currently expected to treat BPs over 180, although evidence there also a bit thin on the ground.

Any other FOAM sites where you found it or who have discussed it already so that we can be sure to give kudos