A randomized, controlled, equivalence study of authorized versus non-authorized deception in a model of pain following third molar extraction

Abstract

Background and rationale When deception is used, a conflict ensues between the need to use it to answer a research question scientifically whilst protecting the participants’ autonomy simultaneously. Authorized deception (where participants are told they will be deceived) is a method that has been proposed to address the traditional “non-authorized” deception. Our study evaluated authorized versus non-authorized deception in a pain model of third molar extraction. Methods Adult patients requiring surgery for third molar extraction were enrolled after consent and randomized to either the authorized or “non-authorized” deception group. Within each group, they were further randomized to receiving either an “expensive” or an “inexpensive” painkiller. All participants actually received the same painkiller. The primary outcome measure was pain, while the proportion of patients taking rescue medication was the secondary outcome measure. All patients were debriefed at study completion. Results The median peak pain score was not significantly different between the groups. A little over 21% patients in the authorized deception group relative to 32.4% patients in the non-authorized group took rescue medication (p = 0.09). In the non-authorized deception group, 30% patients in the “inexpensive” group relative to 34.5% patients in the “expensive” group took rescue medication (p > 0.05). In the authorized deception group, 12.5% patients who received “expensive” relative to 30.4% who received the “inexpensive” painkiller took rescue medication (p = 0.04). Conclusions While our study showed equivalence of the two deception modalities, authorized deception may not be truly sterile.