OBJECTIVE: To share lessons learned from developing a reliable and valid questionnaire for adequacy of sedation in pharmacologically paralyzed critically ill patients. METHODS: In phase 1, seven experts listed 21 characteristics describing anxiety in pharmacologically paralyzed patients. In phase 2, two scenarios were created illustrating the experience of paralysis: one with and one without receiving a sedative. A convenience sample of 30 people evaluated scenarios to determine the importance of characteristics obtained from phase 1 using a five-point scale. Items were reduced to the 10 most important characteristics (mean > 3). Based on these results, the final instrument consisted of 12 questions: 2 categorical addressing memory of the experience and 10 referred to characteristics of anxiety. In phase 3, two groups of critically ill patients were administered the questionnaire: 1) sedated only and 2) sedated and pharmacologically paralyzed. The questionnaire was administered twice for reliability. Questionnaire results were compared to subjective and objective sedation monitoring tools for validity. Calculated sample size was 20 for each group. RESULTS: During six months, 21 patients consented to participate. Twelve patients died and nine patients (6 sedated, 3 sedated/paralyzed) were administered questionnaires. Five patients (3 sedated, 2 sedated/paralyzed) did not remember the intensive care unit experience. Two of three patients in the sedated group who answered the questionnaire found it difficult to remember over time. One sedated/paralyzed patient who answered the questionnaire received a sedative without amnesic properties and felt anxious during therapy. The distressful feeling of this patient was comparable to findings of the objective sedation tool. CONCLUSIONS: Mortality in this critically ill patient population was high. Due to amnestic properties of sedatives most patients did not remember the experience. Of patients who remembered, their memory deteriorated over time. Based on lessons learned, it may require 2-3 years to achieve the necessary sample size.