abstract
- OBJECTIVE: Acute postconcussive headaches are problematic for children after mild traumatic brain injury. There are no evidence-based guidelines for their management. This pilot study aims to assess the feasibility and efficacy of routine analgesia administration. METHODS: A four-arm open-label randomized controlled trial pilot/feasibility study was conducted: (i) acetaminophen, (ii) ibuprofen, (iii) alternating acetaminophen and ibuprofen and (iv) a control group. Children and youth 8 to 18 years of age presenting to emergency department with headache within 48 hours of their first concussion were recruited consecutively and sequentially randomized. Children with abnormal neuroimaging, history of previous concussions and bleeding disorder were excluded. A headache survey was administered at recruitment. All participants were provided with standard concussion management education and were also instructed on how to use the headache diary for the 1-week study follow-up period. The diary captures (i) headache days, (ii) number of headaches, (iii) headache intensity and (iv) return-to-school information. Feasibility was assessed based on study recruitment and compliance. RESULTS: There were no feasibility concerns with the recruitment and no major compliance issues. Patients on acetaminophen, ibuprofen or both had significantly less headache days, episodes of headache and lower headache intensity than did the standard care group. Patients on both ibuprofen and acetaminophen (79.0%) and on ibuprofen alone (61.0%) were more likely to be back at school 1 week postinjury as compared with the acetaminophen group (33.3%) and the standard care group (21.1%). CONCLUSION: Results showed routine analgesia administration was feasible and effective for postconcussive headache management. A larger full-scale randomized controlled trial is required to further assess the efficacy with longer follow-up, a wider variety of patients and more concussion related outcomes.