Effect of intranasal dexmedetomidine or intranasal midazolam on prevention of emergence agitation in pediatric strabismus surgery: A randomized controlled study

Abstract

Background: Following strabismus surgery under sevoflurane anesthesia children often experience emergence agitation (EA) and postoperative vomiting (POV). This study compared the effects of premedication with intranasal dexmedetomidine, midazolam, and placebo on postoperative EA and POV. Methods: 105 children (aged 1-7 years) undergoing elective strabismus surgery under sevoflurane anesthesia were randomly assigned to one of three groups (n = 35 each). Preoperatively, group D received intranasal (IN) dexmedetomidine (1 lg/kg), group M received IN midazolam (0.1 mg/kg), and group C received (1 ml) IN normal saline. Agitation scores (Pediatric Anesthesia Emergence Delirium [PAED] scale) and POV were assessed in post-anesthesia care unit (PACU). The incidence of intraoperative Oculocardiac Reflex OCR events, Time to spontaneous eye opening, Postoperative pain score, total consumption of rescue analgesia and time to discharge from PACU were also assessed. Results: 98 children completed the study. Incidence of agitation (defined as PAED score P 10) was significantly higher in the control group and the midazolam group than in the dexmedetomidine group (P = 0.014), and the number of patients who developed severe agitation requiring fentanyl (PAED score P 15) was also higher in the control group (P = 0.042). There was no significant difference between the incidence of POV in the PACU between the control group (28%) and the midazolam group (21%); however, the incidence was significantly lower in the dexmedetomidine group (15%). The number of intraoperative OCR events was significantly higher in the control group (39%) than in the dexmedetomidine (0%; P = 0.006) and in the midazolam group the incidence was higher than the dexmedetomidine (9%; 3 events) but did not reach statistical significance.

The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis

“…The included articles were undertaken from 2008-2016 in eight different countries: USA (one), Turkey (one), Saudi Arabia (one), India (three), China (three), Egypt (two), Mexico (one), and Oman (one). Four studies 13,18,19,22 compared the effects of intranasal dexmedetomidine with those of oral midazolam, and six studies 10,11,14,16,17,21 compared the effects of intranasal dexmedetomidine with those of intranasal midazolam. One study compared intranasal dexmedetomidine with intranasal clonidine, 15 and two studies compared intranasal dexmedetomidine with intranasal normal saline.…”

“…12,20 One study additionally compared intranasal dexmedetomidine with intranasal ketamine, 14 and one study additionally compared intranasal dexmedetomidine with intranasal normal saline. 10 The characteristics of the included studies are summarized in Table 1.…”

“…All of the included studies used a random allocation method. Ten studies [10][11][12][13][14][15][16][17][18]22 described the allocation concealment in detail, and six studies 10,11,13,15,16,22 concretely explained their blinding methods. The risk of allocation concealment and blinding was unclear in the other studies.…”

“…The incidence of emergence agitation was extracted from six trials. 10,11,13,15,16,18 Emergence agitation was evaluated by a four-point sedation scale, 16,18 modified Yale scale, 13 Pediatric Anesthesia Emergence Delirium scale, 10 or Aonos four-point scale. 15 Intranasal dexmedetomidine premedication showed no evidence of reducing emergence agitation when compared with other premedication treatments.…”

“…The incidence of postoperative nausea and vomiting was extracted from six trials 10,11,[14][15][16][17] including 496 patients.…”