Double‐blind Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department

Abstract

Objective: The objective of this study was to compare anxiolysis with intranasal dexmedetomidine, an alpha-2 agonist, versus intranasal midazolam for pediatric laceration repairs. Methods:We performed a double-blind, randomized controlled trial of 40 patients 1-5 years with lacerations requiring suture repair in an academic pediatric emergency department (ED). Patients were randomized to receive either intranasal dexmedetomidine or intranasal midazolam. Our primary outcome measure was the anxiety score at the time of patient positioning for the laceration repair. We chose this time point to isolate the anxiolysis from the medications prior to intervention. Patient encounters were videotaped and scored for anxiety at multiple time points using the modified Yale Preoperative Anxiety Scale. The scale is 23.3-100 with higher scores indicating higher anxiety. We also evaluated these scores as a secondary outcome by dichotomizing them into anxious versus not anxious with a previously validated score cutoff.Results: Of the 40 patients enrolled, 20 in the dexmedetomidine group and 18 in the midazolam group completed the study and were included in the analysis. The median age was 3.3 years (range = 1.0-5.4 years). The median baseline anxiety score was 48.3. The anxiety score at position for procedure for patients receiving dexmedetomidine was 9.2 points lower than those receiving midazolam (median difference = 9.2, 95% confidence interval = 5 to 13.3; median score for dexmedetomidine = 23.3, median score for midazolam = 36.3). The proportion of patients who were classified as not anxious at the position for procedure was significantly higher in the dexmedetomidine group (70%) versus the midazolam group (11%). The number needed to treat with dexmedetomidine instead of midazolam to obtain the result of a not anxious patient at this time point was 1.7 patients. There were also significantly more patients who were classified as not anxious at the time of wound washout in the dexmedetomidine group compared to the midazolam group (35% vs. 6%). Dexmedetomidine and midazolam performed similarly with respect to all other measures including anxiety at other time points, parental perceived anxiety, parent and proceduralist satisfaction, procedural success, complications, and time in the ED. There were no serious adverse events seen in either group.Conclusions: Intranasal dexmedetomidine is an alternative anxiolytic medication to intranasal midazolam for pediatric laceration repairs, performing similarly in our study, except that patients who received dexmedetomidine had less anxiety at the time of positioning for procedure.ACADEMIC EMERGENCY MEDICINE 2016;23:910-917

Is dexmedetomidine the gold standard for pediatric procedural sedation and anxiolysis?

“…As we didn't randomize the patients, comparison between the drugs is flawed, but no failed sedations occurred in the DEX patients, and no adverse events with clinical relevance were observed. Parent satisfaction, although not directly measured by Neville et al, 1 was also greater with IN DEX.…”

“…I would like to discuss the article "Double-blind randomized controlled trial of intranasal dexmedetomidine versus intranasal midazolam as anxiolysis prior to pediatric laceration repair in the emergency department," by Neville et al, 1 which is currently in press in the Academic Emergency Medicine Journal. The authors randomized 38 children to receive either intranasal dexmedetomidine (DEX) or intranasal midazolam before laceration repairs, and chose as primary outcome the anxiety score at the time of patient positioning for the repair.…”

“…One concern with the study conducted by Neville et al 1 was that the anxiety score at positioning for procedure of the patients receiving DEX was 9.2 points lower than that of the patients receiving midazolam, according to the modified Yale Preoperative Anxiety Scale, which the authors used as a reference. Although other baseline characteristics between the two groups (DEX and midazolam) were similar, these random findings can cause a potential bias to the final conclusions.…”

Dexmedetomidine for refractory adrenergic crisis in familial dysautonomia

“…In this regard, the potential role of intranasal dexmedetomidine for FD patients is appealing. Intranasal dexmedetomidine has been used to pre-medicate pediatric patients undergoing diagnostic and therapeutic procedures to provide light sedation and blunt sympathetic activity [2, 8, 15, 18, 28]. Because initial management of FD crises typically occurs at home, the availability of a medication with rapid onset, effectiveness via the intranasal route, and minimal risk of respiratory depression, would pose a significant therapeutic innovation.…”

Intranasal deksmedetomidin er gunstig som premedikasjon til barn – sett fra anestesisykepleieres perspektiv

“…Deksmedetomidin har analgetikum-og anestetikumsparende effekt, påvirker i minimal grad respirasjonen og kan administreres via ulike ruter (1)(2)(3). Intranasal rute er lite traumatisk, og deksmedetomidin er smakløst, luktfritt og smertefritt ved bruk i neseslimhinnen, noe som gjør at medikamentet tolereres godt av barn (4,5).…”