Old Is (Not) Gold: Midazolam Monotherapy versus Midazolam Plus Fentanyl for Sedation during Cardiac Catheterization

Abstract

Objective. We aimed to study the differences in perception of pain during cardiac catheterization with midazolam monotherapy compared to the current standard of midazolam plus fentanyl. Background. Procedural sedation is important to ensure comfort and safety in patients undergoing left heart catheterization. Despite the widespread use of midazolam and fentanyl for procedural sedation, the effectiveness of this dual agent approach to sedation has never been studied in comparison to midazolam monotherapy. Methods. A total of 129 patients undergoing sedation for outpatient elective cardiac catheterization were randomly assigned to either midazolam monotherapy (n = 69) or combination of midazolam and fentanyl (n = 60). The primary outcome was assessment of pain perception prior to discharge by patient completion of a pain questionnaire. Participants were asked if they experienced any pain during their procedure (yes/no) and, if yes, asked to rate their overall pain level using a 10-point Likert scale that ranged from 1 (minimal pain) to 10 (worst pain imaginable). Results. Most patients (n = 94, 73%) reported no pain during their procedure. Patients sedated with midazolam monotherapy reported similar average pain scores compared to patients sedated with the combination of midazolam and fentanyl (1.1 vs. 1.1, p = 0.95 ). Conclusions. Among patients undergoing elective cardiac catheterization, no significant differences in pain scores were noted between sedation with midazolam alone compared to midazolam and fentanyl. Due to fentanyl’s unfavorable interaction with P2Y12 agents, increased costs, and addiction potential, it is imperative that cardiologists revisit the role of effective procedural sedation with a single agent and avoid the use of fentanyl.

Timing of sedation and patient‐reported pain outcomes during cardiac catheterization: Results from the UNTAP‐intervention study

“…The combination of opioid and benzodiazepines is common midazolam. 6,21 Patients treated with midazolam monotherapy reported no significant differences in pain scores compared to midazolam and fentanyl combination therapy. Furthermore, lowquality evidence suggests that sedation levels are higher with midazolam versus placebo, however, anxiety and pain were not reduced.…”

“…with differences seen between geographic location, institution, and operator 6 and more frequently used in the United States. 2 Common patient reported outcomes include pain and anxiety, yet pain is characterized as "minimal" and rarely localized, creating a paucity of best practice recommendations.…”

“…2 Common patient reported outcomes include pain and anxiety, yet pain is characterized as "minimal" and rarely localized, creating a paucity of best practice recommendations. 6,19,20 The numeric rating scale (0-10) is used most frequently and yet, overall patient-reported pain remains low (less than 3.5/10). To treat pain, guidelines do not include recommendations on optimal dose, preferred choice of procedural medications, or specific medication combinations.…”

“…[2][3][4][5] For angiography, average doses range from 0.5 to 6 mg midazolam, 0 to 125 mcg of fentanyl, 5 to 10 mg diazepam, and verying doses and comibination of diphenhydramine and morphine. [5][6][7] There remains little evidence to guide procedural sedation practices in the CC lab, despite the frequent usage of this common diagnostic and interventional procedure. 5 Available clinical guidelines highlight the importance of assessing patient hemodynamics, respiratory status, and accounting comorbidity risks, but remain devoid of patient-reported outcomes, including satisfaction, patient-reported procedural experiences, and/or discomfort.…”

“…The use of procedural sedation is commonly used in the United States during CC to ensure procedural success, enhance patient comfort, and to alleviate anxiety during the procedure 2–5 . For angiography, average doses range from 0.5 to 6 mg midazolam, 0 to 125 mcg of fentanyl, 5 to 10 mg diazepam, and verying doses and comibination of diphenhydramine and morphine 5–7 . There remains little evidence to guide procedural sedation practices in the CC lab, despite the frequent usage of this common diagnostic and interventional procedure 5 .…”