Adequacy of informed consent for lumbar puncture in a pediatric emergency department

Objective: To determine whether informed consent is adequately obtained by documentation of appropriate risks, benefits, alternatives, and procedure explanation for children who had a lumbar puncture (LP) in a pediatric emergency department (PED). Methods: Authors agreed on the criteria for appropriate informed consent for LP, including risks and benefits of the procedure, alternatives to doing the procedure, explanation of the procedure including the purpose of the LP, and a signature of a witness. A retrospective chart review was done for all children who had LP during a 1-year period in a PED. Information documented on a general procedure consent form was analyzed. Results: There were 336 patients who had LP in the PED during a 1-year period. Mean (SD) age of patients was 37.8 (61.9) months (median age, 1.6 months), and 56.5% were boys. Consent was obtained by attending physicians (18.9%), pediatric emergency medicine fellows (7.1%), residents (73.6%), and medical students (0.3%). Documented risks of the LP included back pain (19.3%), infection (88.2%), bleeding (86.5%), apnea for infants 1 year or younger (9.5%), and post-LP headache for children 10 years and older (44.9%). Benefits of the procedure were documented for 36.1%, alternatives for 12.5%, explanation of the procedure for 45.9%, purpose for 94.3%. There was no statistically significant difference for training level of person obtaining consent and risks documented. However, pediatric emergency medicine fellows documented benefits more frequently (P = 0.005), residents documented alternatives more frequently (P = 0.006), and attending physicians documented explanation of the procedure more frequently (P = 0.005). Conclusions: Risks, benefits, alternatives, and explanation of the LP procedure are not adequately documented on consent forms in the PED. Although the actual discussion with guardians is unknown, these data imply that informed consent may not have been properly obtained before the LP was performed. In the event of a complication and subsequent malpractice lawsuit, clinicians may be unable to demonstrate they adequately informed a guardian about the LP.