Date: March 7th, 2014
Guest Skeptic: Dr. Anthony Crocco. Associate Professor, McMaster University, Medical Director and Division Head McMaster Children’s Hospital Emergency Department.
Case: 11-year-old snowboarder fails to land epic jump. She was wearing helmet. There was a brief loss of consciousness and she is amnestic to the event. The only complaint is a mild headache. Her examination is normal and a shared decision is made to observe her rather than getting a CT scan. She is ultimately diagnosed with a concussion. When leaving the department she wants to know when can she go back shreddin’ the gnar?
Background: Pediatric traumatic brain injury (TBI) is a leading cause of death and disability. The Center for Disease Control (CDC) has called it a national health problem. TBIs are responsible for close to 500,000 ED visits, over 35,000 hospitalizations and more than 7,000 deaths/yr in the USA. TBI is considered mild 75% of the time. Most patients with TBI are discharged from the ED with active concussive symptoms.
TBI represents a challenging situation to emergency physicians. We do not want to miss a significant intracranial lesion while at the same time want to avoid ionizing radiation.
So how do you decide when to get neuroimaging? The best clinical decision instrument and the one we use at McMaster Children’s Hospital is PECARN (Pediatric Care Applied Research Network). It has been externally validated and found to be better than the CHALICE Tool and the CATCH Tool (Easter et al Annals Emergency Medicine).
PECARN has been collecting data on patients with head trauma since 2004. It is a federally funded multi-institutional network for research in pediatric emergency medicine.
They successfully enrolled 34,000 patients for the derivation of two clinical decision rules (one for children < 2 years and one for children > 2 years), and an additional 9,000 patients to validate the decision rules. This was published by Kuppermann N et al in the Lancet 2009.
Assuming no patients with significant intracranial injury were missed with their follow-up mechanism, the rule had the following to predict the lack of ciTBI:
- 97% sensitivity and 59% specificity for older children
- 99% sensitivity and 54% specificity for age <2yrs old
The overall prevalence of ciTBI was 0.9% (less than 1/100). Patients requiring neurosurgery was 0.14% (1/700). No patients died out of 34,000.
Clinical Question: Is there benefit to recommending strict rest after a child has a concussion?
Reference: Thomas DG et al. Benefits of Strict Rest After Acute Concussion: A Randomized Controlled Trial. Pediatrics. January 2015
- Population: Patients aged 11-22 years old presenting to the emergency department with acute (<24 hours) diagnosis of concussion.
- Exclusion: Could not speak English, couldn’t consent, had pre-existing intellectual disability or mental health issue, had a previously diagnosed intracranial injury, were being admitted. Patients were also excluded if they lived >1 hour from the investigation center or at the discretion of the recruiting physician.
- Intervention: Strict rest at home for five days (no school, work or activity) followed by stepwise return to activity.
- Comparison: Rest for 1-2 days (at the discretion of the treating physician) followed by a return to school and stepwise return to activity.
- Outcome: Compliance with physical and mental activity recommendations, symptoms, neurocognitive performance (ImPACT) and balance.
Authors’ Conclusions: “Recommending strict rest for adolescents immediately after concussion offered no added benefit over the usual care.”
Quality Checklist for Randomized Clinical Trials:
- The study population included or focused on those in the ED. Yes The patients were aged 11-22 years, so not strictly pediatric by most standards. The patients were, however, recruited from the ED.
- The patients were adequately randomized. Yes
- The randomization process was concealed. Yes
- The patients were analyzed in the groups to which they were randomized. Yes
- The study patients were recruited consecutively (i.e. no selection bias). No
- The patients in both groups were similar with respect to prognostic factors. No
- All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No
- All groups were treated equally except for the intervention. Unsure
- Follow-up was complete (i.e. at least 80% for both groups). Yes
- All patient-important outcomes were considered. No
- The treatment effect was large enough and precise enough to be clinically significant. Yes
Key Results: Both groups reported a ~20% decrease in physical activity and energy expenditure for the 5 days post-injury. There was more reported high and moderate mental activity in the usual care group on days 2-5 (8.33 vs. 4.86 hours, P = 0.03).
With regards to efficacy, 67% of patients in the usual care group experienced symptom resolution during follow-up compared to 63% in the strict group (P = 0.82) so no difference.
It took 3 days longer for 50% of patients in the strict group to report symptom resolution. The strict group had more post-concussive symptoms compared to the usual care group over the 10 day follow-up period (70 vs. 50, P <0.03) and had greater post-concussive symptom scale (PCSS) scores (188 vs. 132, P < 0.03).
There were no significant differences noted in computer-based neurocognitive tests and balance scores noted and no significant differences in neuropsychological assessments except for the Symbol Digit Modalities Test for which the usual group performed worse at day three and better at day ten.
This is a novel, single-center study examining a topic that we often struggle with in the emergency department, specifically, how long to keep someone resting post-concussion.
There are some minor limitations of this study: The patients were aged 11-22 years. It is questionable whether this study can be generalized to younger pediatric patients;
The two groups did differ significantly in terms of age with the strict rest group being older. The impact of this difference is unknown;
Outcome measures such as re-presentation to emergency department and proportion of patients with symptoms beyond 10 days were not described. In addition, 11% of patients were lost to follow-up.
This study has opened the door to a very interesting line of inquiry, and further research will be very useful. For the time being, however, there is evidence to support a two-day rest period following a concussion with a gradual return to activity.
Keeping a child at strict rest for five days post-concussion appears to offer no benefit, and there is evidence of harm from this strategy.
Comment on Authors’ Conclusion Compared to SGEM Conclusion: We would agree with the authors that there is no added benefit to five days of strict rest over two days and we would add that the five-day strict strategy appears to cause more harm.
SGEM Bottom Line In children with concussion, two days of rest followed by a gradual return to activity is preferred over five days of rest followed by a gradual return to activity. The longer strict rest period appears to cause more post-concussive symptoms.
Case Resolution: You send the shredder home with your hospital’s standard concussion information.
Clinical Application: In children presenting with concussion we can limit the rest period, post-concussion, to two days followed by gradual return to activity.
What do I tell my patient? Your child has a concussion and they need to take two days off school and sports. They can slowly return to activity after that period of time.
Case#2: Same 11-year-old snowboarder who has a mild headache after her concussion. The mother wants to know if there is anything else besides acetaminophen or ibuprofen to treat her daughter’s headache?
Clinical Question: What about using intravenous hypertonic saline as a therapy for paediatric concussive pain?
Background: Hypertonic saline as a therapy for increased intracranial pressure was first described almost 100 years ago by Weed and McKibben in the American Journal of Physiology.
Reference: Lumba-Brown et al. Hypertonic Saline as a Therapy for Pediatric Concussive Pain: A randomized controlled trial of symptom treatment in the emergency department. Pediatric Emergency Care March 2014
- Population: Children 4-17 years old with acute closed head injury, GCS>13, moderate to severe concussive symptoms and had a CT scan prior to enrollment
- Excluded: GCS<13, CT bleed, Seizure, chronic migraines, EtOH, drugs, associated injuries, needing narcotics, trauma patients, intubated or pregnant.
- Intervention: Standard care + 10cc/kg of 3% hypertonic saline (max 1L) over 1 hour
- Control: Standard care + 10cc/kg of normal saline (max 1L) over 1 hour
- Primary Outcome: Change in self reported pain using Wong-Baker FACES Pain Rating Scale
- Secondary Outcome: Change in pain; nausea/vomiting; other symptoms of concussion within 2-3 days of presentation
Authors’ conclusions: “Three percent HTS [hypertonic saline] is more effective than NS [normal saline] in acutely reducing concussion pain in children.”
Quality Checklist for Randomized Clinical Trials:
- Study population included or focused on those in the ED. YES. Patients were recruited from a tertiary care pediatric ED.
- The patients were adequately randomized. YES. Computerized randomization was used.
- The randomization process was concealed. YES
- The patients were analyzed in the groups to which they were randomized. YES
- Study patients recruited consecutively. NO. Patients were recruited by convenience sample. Recruiting changed in the last 6 months to alternating two week blocks per month.
- Patients were similar in both groups with respect to prognostic factors. NO. There was significantly higher pain in the HTS group at the onset and a higher level of analgesia use in the HTS group prior to enrolment.
- All participants were unaware of group allocation. YES – patients and caregivers were blinded to allocation.
- All groups were treated equally except for the intervention. UNSURE. Although both groups received standard care, differences in this care are not specified.
- Follow-up was complete: YES
- All patient-important outcomes were considered. UNSURE. Although short-term symptoms were studied, we are unsure of the long-term effect of hypertonic saline on neuro-cognitive healing post concussion.
- The treatment effect was large enough and precise enough to be clinically significant. UNSURE. Although a statistically significant difference was noted in the change in pain scores, benefitting the HTS group, this difference is questionable given the major limitations of this study.
Key Results: The change in pain from pre-treatment to 1 hour post-treatment was significantly better at 3.52 for the HTS group than 1.14 for the NS group (p<0.001). In addition the change in pain at 2-3 days was significantly better in the HTS group (4.61) compared to the NS group (3) with a p = 0.01.
This study explores an interesting therapeutic possibility for children with moderate to severe concussions after an acute head injury. The authors’ conclusions are over-ambitious and careful consideration of the paper’s limitations needs to be addressed.
The sample size was too small. The original plan was to recruit a total of 104 patients for this trial. The authors failed to reach this number and only recruited a total of 44 patients. The low number of patients put the study at risk of significant differences between study groups, which we see. Specifically, in this study, the HTS group had higher initial pain scores which could made it easier to see an greater absolute change in pain scores over time.
Generalizability is an issue for these patients to our patients. This study only included patients who had a CT scan and therefore it is questionable whether these results can be applied to all patients presenting with concussive symptoms. Also, it would be unethical to perform an unnecessary CT scan just to ensure the utility of this therapy. The authors also had a number of exclusion criteria, including post-traumatic seizure and history of chronic migraines, which may preclude the generalizing of these results to the average ED patient.
Follow-up was not as planned. The initial plan was a 2-3 day follow-up. The average follow-up was 5 days with many patients being followed up at 7 days. This may have instilled recall-bias, undermining the results from the 2-3 day pain scales.
Comment on Authors’ Conclusion Compared to SGEM Conclusion: We disagree with the authors. Based on significant limitations of this study, hypertonic saline is not ready for prime-time use in patients with moderate-severe concussion.
SGEM Bottom Line: Although an interesting therapeutic modality to be further studied, IV hypertonic saline is not ready for routine use in children with moderate-severe concussions.
Clinical Application: None at this time.
Keener Kontest: Last weeks winner was Chris Belcher from Kentucky. He knew the ketamine was first known by its alpha-numeric designation CI-581.
Listen to the podcast to hear this weeks keener question. If you know the answer send me email to TheSGEM@gmail.com with “keener” in the subject line. The first person with the correct answer will receive a cool skeptical prize.