Lidocaine Pretreatment Reduces the Discomfort of Intranasal Midazolam Administration: A Randomized, Double‐blind, Placebo‐controlled Trial

Abstract

Objective Intranasal (IN) midazolam is a commonly prescribed medication for pediatric sedation and anxiolysis. One of its most frequently encountered adverse effects is discomfort with administration. While it has been proposed that premedicating with lidocaine reduces this undesirable consequence, this combination has not been thoroughly researched. The objective of our study was to assess whether topical lidocaine lessens the discomfort associated with IN midazolam administration. Methods This was a double‐blind, randomized, placebo‐controlled trial performed in an urban, academic pediatric emergency department. Children 6–12 years of age who were receiving IN midazolam for procedural sedation received either 4% lidocaine or 0.9% saline (placebo) via mucosal atomizer. Subjects were subsequently given IN midazolam in a similar fashion and then rated their discomfort using the Wong‐Baker FACES Pain Rating Scale (WBS). The primary endpoint of WBS score was analyzed with a two‐tailed Mann‐Whitney U‐test, with p < 0.05 considered statistically significant. Results Seventy‐seven patients were enrolled over a consecutive 8‐month period. One child was excluded from analysis due to a discrepancy in recording the drug identification number. Study groups were similar in regard to demographic information and indication for sedation. Subjects who received IN lidocaine reported less discomfort with IN midazolam administration (median WBS = 3, interquartile range [IQR] = 0–6) than those who received placebo (median WBS = 8, IQR = 2–9; p = 0.006). Conclusions Premedication with topical lidocaine reduces the discomfort associated with administration of IN midazolam (ClinicalTrials.gov, NCT02396537).

Comparison of preadministered and coadministered lidocaine for treating pain and distress associated with intranasal midazolam administration in children: A randomized clinical trial

“…4 Additionally, previous studies have shown that preadministered and coadministered lidocaine are more effective than placebo in decreasing pain and distress associated with intranasal administration of midazolam or acidic solutions in both children and adults. 7,8 The mean scores of pain and distress associated with intranasal midazolam administration observed in both groups of children who received preadministered and coadministered lidocaine were not scores that typically represent no pain or mild pain. [9][10][11][12] This differs from a previous study of children aged 5 to 50 months who received intranasal lidocaine before intranasal midazolam and whose parents assigned pain scores associated with intranasal midazolam administration that were no >2 out of 10.…”

“…[4][5][6] The pain and distress associated with intranasal midazolam administration can be decreased by using intranasal lidocaine. [5][6][7] One method involves medicating with intranasal lidocaine before intranasal midazolam administration (preadministered lidocaine), which requires 2 separate administrations. [5][6][7][8] A second method involves mixing the lidocaine and midazolam and administering the premixed solution (coadministered lidocaine), which requires only a single administration.…”

“…[5][6][7] One method involves medicating with intranasal lidocaine before intranasal midazolam administration (preadministered lidocaine), which requires 2 separate administrations. [5][6][7][8] A second method involves mixing the lidocaine and midazolam and administering the premixed solution (coadministered lidocaine), which requires only a single administration. 8 Both methods are effective in decreasing the pain associated with intranasal midazolam and other acidic solutions.…”

“…8 Both methods are effective in decreasing the pain associated with intranasal midazolam and other acidic solutions. [6][7][8] However, it is unknown whether the 2 methods produce comparable decreases in pain and distress associated with intranasal midazolam administration in children.…”

“…The pain and distress associated with intranasal midazolam administration can be decreased by using intranasal lidocaine 5‐7 . One method involves medicating with intranasal lidocaine before intranasal midazolam administration (preadministered lidocaine), which requires 2 separate administrations 5‐8 .…”