The purpose of this research study was to develop a score to assess intranasal (IN) drug administration discomfort and then assess 3 different approaches to reduce the pain associated with the administration of an IN citrate study solution.
After Institutional Review Board approval and with informed consent, volunteers intranasally received 0.3 M solution of citrate, on 4 different days. In stage 1, the citrate was administered via syringe or by aerosol. Stage 2 compared the IN citrate before and 60 seconds after 2% lidocaine was given. Stage 3 compared the IN citrate to an IN mixture of 2% lidocaine and citrate. A placebo of IN saline was also used on one occasion. The degree of pain, burning, and unpleasant taste was recorded using a scale of 1 to 10 to give an overall intranasal discomfort score (INDS).
The citrate proved significantly more unpleasant and painful than the placebo saline. The mean INDS was 12.1, which was significantly higher following IN citrate compared to saline. Lidocaine, both pretreatment and mixed, significantly reduced the INDS.
The intranasal discomfort score appeared reproducible for assessing painful intranasal drug administration. The addition of lidocaine appeared to reduce the discomfort of intranasal citrate in adult volunteers.