Podcast: Play in new window | Download

Subscribe: RSS

 

[display_podcast]

Date:  June 2nd, 2014 

Guest Skeptics: Dr. Anthony Crocco Division Head and Medical Director of Pediatrics  Emergency Medicine at McMaster University.

Case Scenario #1: A two year old child presents to the emergency department with a simple laceration on his forehead. You decide to use a tissue adhesive rather than sutures.

Question #1: Does a topically applied analgesic decrease pain in children undergoing laceration repair with tissue adhesive?

kid-cutBackground: Oligoanalgesia is defined as poor pain management through the underuse of analgesia. It is well known that many patients presenting to the emergency department receive little or no analgesia to manage their pain (Wilson et al). There are several factors felt to contribute to this poor pain management (Motov and Khan). Children represent just one group that is less likely to receive adequate analgesia. (Brown et al, Selbst and Clark). Other factors include elderly patients (Cavalieri TA), certain ethnicities, mental illness (Simon et al) and lack of health insurance (Hosteller et al).

Reference: Harman S, Zemek R et al. Efficacy of pain control with topical lidocaine-epinephrine-tetracaine during laceration repair with tissue adhesive in children: A randomized controlled trial. CMAJ 2013;

  • Population: Children (3mo-17yrs) presenting to the ED with a laceration <3cm
  • Intervention: Topically applied lidocaine-epinephrine-tetracaine (LET) gel 45min prior to adhesive repair
  • Comparison: Topically applied placebo gel 45min prior to adhesive repair
  • Outcome:
    • Primary: Amount of pain experienced during the adhesive repair.
    • Secondary: Physician rating of difficulty of repair; physician reporting of wound hemostasis prior to repair; physician prediction of experimental group (i.e. LET vs. placebo); unscheduled follow-up visits.

Authors’ Conclusions: “Treating minor lacerations with lidocaine-epinephrine-tetracaine before wound closure with tissue adhesive reduced ratings of pain and increased the proportion of pain-free repairs among children aged 3 months to 17 years. This low-risk intervention may benefit children with lacerations requiring tissue adhesives instead of sutures.”

checklist-cartoonBEEM Quality Checklist for Randomized Control Trials:

  1. The study population included or focused on those in the ED. Yes
    • Comment: Patients were recruited from a tertiary-care pediatric ED
  2. The patients were adequately randomized. Yes
  3. The randomization process was concealed. Yes
  4. The patients were analyzed in the groups to which they were randomized. No
  5. The study patients were recruited consecutively (i.e. no selection bias). Unsure
  6. The patients in both groups were similar with respect to prognostic factors. Yes
  7. All participants (patients, clinicians, outcome assessors) were unaware of group allocation. Yes
  8. All groups were treated equally except for the intervention. Yes
  9. Follow-up was complete (i.e. at least 80% for both groups). No
  10. All patient-important outcomes were considered. No
  11. The treatment effect was large enough and precise enough to be clinically significant. Yes

Key Results:

  • Level of pain (measured by Visual Analogue Scale) was less in the LET group compared to placebo (median 0.50, IQR 0.25-1.50 vs. median 1.00, IQR 0.38-2.50; p=0.01).  51.6% children experienced no pain with LET compared to 28.3% children with placebo (RR 0.54, 95%CI 0.37-0.80).
  • Wound hemostasis was better in the LET group (78.2%) compared to the placebo group (59.2) (p<0.008).
  • Difficulty in wound repair was not significantly different.
  • There was no significant differences in follow-up visits between groups.
  • Physicians were able to correctly identify the experimental group in 72.9% patients.

Unknown-1Commentary: Overall this is a well-performed study on an important topic in pediatric emergency medicine. Controlling pain in children is often difficult and LET gel is a non-invasive method of helping achieve this. This study shows that a significantly higher group of children were pain-free with their procedure.

There were a number of limitations to this study which included:

  1. No intention-to-treat analysis.
  2. Poor follow-up. Ability to follow-up was not made a mandatory requirement of inclusion into the study, so not surprisingly, the follow-up rate was lower. This undermines any conclusions about unplanned return-to-care data.
  3. It would be interesting to know if there is any impact on wound healing by LET gel with tissue adhesive. This has not been raised as a major concern, but could have been studied with an established wound assessment score as has been done previously with tissue adhesives and absorbable stitches.
  4. Unblinding – almost three-quarters of physicians knew which children where in the treatment group.

Bottom Line: LET gel should be used routinely prior to repairing simple lacerations in children.

Case Resolution: You get the LET out and apply it before using tissue adhesive on this two year old with a forehead laceration.

Clinical Application: Use LET in children with lacerations in the emergency department.

What do you tell Patients: We are going to put on some “magic” gel that will help take the pain away.

Kidz-Gear11

Clinical Scenario #2: Child presents to the emergency department and requires an intravenous line.

Question #2: Does adding ambient music to standard care of pediatric patients prevent distress during painful procedures?

Reference: Hartling L, Newton AS et al. Music to reduce pain and distress in the pediatric emergency department. A randomized clinical trial. JAMA Pediatrics 2013

  • Population: Children 3-14 years old presenting to a pediatric ED, requiring an IV, and having an understanding of English.
  • Intervention: Standard care with music played through an ipod dock (The Planets Op. 32 Jupiter, Storms in Africa, Disco Beat, and Sunny Days) played at a standardized volume, played until the procedure was complete.
  • Comparison: Standard care without music
  • Outcome:
    • Primary: Patient distress measured with the Observational Scale of Behavioural Distress-Revised (OSBD-R).
    • Secondary: Change in self-reported pain from baseline; heart rate; parent and health care provider satisfaction; parental anxiety.

Authors’ Conclusions: “Music may have a positive impact on pain and distress for children undergoing intravenous placement. Benefits were also observed for the parents and health care providers.”

checklist-cartoonBEEM Quality Checklist for Randomized Control Trials:

  1. The study population included or focused on those in the ED. Yes
    • Comment: The patients were exclusively recruited from the emergency department.
  2. The patients were adequately randomized. Yes
  3. The randomization process was concealed. Yes
  4. The patients were analyzed in the groups to which they were randomized. Yes
  5. The study patients were recruited consecutively (i.e. no selection bias). No
  6. The patients in both groups were similar with respect to prognostic factors. Unsure
  7. All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No
  8. All groups were treated equally except for the intervention. Yes
  9. Follow-up was complete (i.e. at least 80% for both groups). Yes
  10. All patient-important outcomes were considered. No
  11. The treatment effect was large enough and precise enough to be clinically significant. No

Key Results: No difference in the change in behavioural distress from pre-procedure to immediately after the procedure. The pain score for the standard care group increased (median, 2; IQR, 0-4) but remained the same for the music group (median, 0; IQR, -4.0 to 0.5) from before to immediately after the procedure (P=0.04).

There was no difference were noted in heart rates or parental anxiety.  There was also no significant differences in parental satisfaction were noted.

Care providers were more satisfied (P=0.02) and found the procedure easier with music (P=0.03).

Unknown-1Commentary: Overall this is an interesting topic. Modification of the stress/pain experience with non-pharmacologic methods is in the best interest of patients, families and caregivers. This is a relatively small study, and the wide confidence intervals and non-significant findings are a product of this. A larger study might more definitively solidify results. There is little downside, however, and this is a very low-cost intervention.

There were a number of limitations to this study which included:

  1. It would have been useful for the researchers to keep track of IV success rates as a secondary outcome measure too.
  2. Blinding was done for those evaluating the video recordings of the subjects, but was, for obvious reasons, not possible for those in the room during the procedure.
  3. There were more boys in the standard care group compared to the experimental group (84% vs. 50%), the effect of which is unknown.
  4. Multiple sub-groups and regression models were used, and these have the high likelyhood of finding erroneous “significant” results. Caution is advised, and in the future it is recommended that these be limited.

Bottom Line: There appear to be some benefits in playing music during painful procedures in children in the ED. This is a low-cost, non-pharmacologic intervention with no adverse effects. It’s a good idea that needs a bit more research, but if the capability is there, can be implemented easily.

Case Resolution: The child care specialist sets up the child to listen to Sunny Days while you start the IV line.

Clinical Application: For children in the emergency department undergoing painful procedures should be offered music as a non-pharmacologic way to address their pain.

What do I tell Patients: We are going to play some music to help you (and us) relax during this procedure!

KEENER KONTEST: Last weeks winner was Chris Nickson from Melbourne, Australia. Chris is one of the forces behind Life in the Fast Lane. He also knew Max Planck was the German physicist who won the Nobel Prize in 1918 and considered one of the founder of quantum theory who said “A new scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die, and a new generation grows up that is familiar with it.”

Listen to this weeks podcast for the Keener question. If you know the answer then send your answer to TheSGEM@gmail.com with “keener“ in the subject line. Be the first one with the correct answer and I will send you a cool SGEM skeptical prize.

Remember to be skeptical of anything you learn, even if you heard it on The Skeptics’s Guide to Emergency Medicine.