A comparison of midazolam and zolpidem as oral premedication in children, a prospective randomized double-blinded clinical trial

Amgad H. Hanna, Davinder Ramsingh, Whitney Sullivan-Lewis, Sarah Cano, Patrick Leiter, Desiree Wallace, Gerald Andrews, Briahnna Austin, Richard Lee Applegate

Research output: Contribution to journalArticle

Abstract

Background: Anxiety associated with pediatric surgery can be stressful. Midazolam is a well-accepted anxiolytic in this setting. However, there are cases in which this medication is not effective. Zolpidem is a short-acting nonbenzodiazepine hypnotic drug that is administered orally and has quick onset of action (~15 minutes), and 2-3 hour duration. Aims: Based on the theory that impaired perception following oral zolpidem administration would suppress the development of anxiety, we sought to compare zolpidem to midazolam for pediatric preoperative anxiety. Methods: This prospective randomized double-blinded clinical trial was designed to compare the effectiveness of oral midazolam and zolpidem for anxiety premedication. Eighty ASA class I-II pediatric patients between 2 and 9 years old, surgery >2 hours, and at least 23 hours postoperative admission were included in the study. Randomization was done with 0.5 mg/kg midazolam or 0.25 mg/kg zolpidem administered orally. The primary outcome measure was between group difference in patient anxiety at the time of separation using the Modified Yale Preoperative Anxiety Scale. Secondary outcomes included emergence delirium and mask acceptance at induction. Results: There was no significant difference in Modified Yale Preoperative Anxiety Scale scores at separation between midazolam (median/interquartile range = 26.7/23.3-36.6) and zolpidem (median/interquartile range = 30.0/23.3-56.6) groups, difference 0.01 (95% CI −3E−5, 3E−2; P = 0.07). Mask acceptance score was significantly better in the midazolam group. There was no significant difference in emergence delirium scores between groups. Conclusion: This study demonstrates that zolpidem, as dosed, was similar to midazolam with regard to anxiety scoring, and inferior with regard to mask acceptance scores.

Original languageEnglish (US)
JournalPaediatric Anaesthesia
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Premedication
Midazolam
Anxiety
Clinical Trials
Masks
Pediatrics
zolpidem
Anti-Anxiety Agents
Random Allocation
Hypnotics and Sedatives
Oral Administration
Outcome Assessment (Health Care)
Pharmaceutical Preparations

Keywords

  • anesthesia
  • anti-anxiety agents
  • anxiety
  • emergence delirium
  • pediatric
  • preanesthetic medication

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Anesthesiology and Pain Medicine

Cite this

A comparison of midazolam and zolpidem as oral premedication in children, a prospective randomized double-blinded clinical trial. / Hanna, Amgad H.; Ramsingh, Davinder; Sullivan-Lewis, Whitney; Cano, Sarah; Leiter, Patrick; Wallace, Desiree; Andrews, Gerald; Austin, Briahnna; Applegate, Richard Lee.

In: Paediatric Anaesthesia, 01.01.2018.

Research output: Contribution to journalArticle

Hanna, Amgad H. ; Ramsingh, Davinder ; Sullivan-Lewis, Whitney ; Cano, Sarah ; Leiter, Patrick ; Wallace, Desiree ; Andrews, Gerald ; Austin, Briahnna ; Applegate, Richard Lee. / A comparison of midazolam and zolpidem as oral premedication in children, a prospective randomized double-blinded clinical trial. In: Paediatric Anaesthesia. 2018.
@article{5f86cf32cc1c4fcba9983a6b84e54b14,
title = "A comparison of midazolam and zolpidem as oral premedication in children, a prospective randomized double-blinded clinical trial",
abstract = "Background: Anxiety associated with pediatric surgery can be stressful. Midazolam is a well-accepted anxiolytic in this setting. However, there are cases in which this medication is not effective. Zolpidem is a short-acting nonbenzodiazepine hypnotic drug that is administered orally and has quick onset of action (~15 minutes), and 2-3 hour duration. Aims: Based on the theory that impaired perception following oral zolpidem administration would suppress the development of anxiety, we sought to compare zolpidem to midazolam for pediatric preoperative anxiety. Methods: This prospective randomized double-blinded clinical trial was designed to compare the effectiveness of oral midazolam and zolpidem for anxiety premedication. Eighty ASA class I-II pediatric patients between 2 and 9 years old, surgery >2 hours, and at least 23 hours postoperative admission were included in the study. Randomization was done with 0.5 mg/kg midazolam or 0.25 mg/kg zolpidem administered orally. The primary outcome measure was between group difference in patient anxiety at the time of separation using the Modified Yale Preoperative Anxiety Scale. Secondary outcomes included emergence delirium and mask acceptance at induction. Results: There was no significant difference in Modified Yale Preoperative Anxiety Scale scores at separation between midazolam (median/interquartile range = 26.7/23.3-36.6) and zolpidem (median/interquartile range = 30.0/23.3-56.6) groups, difference 0.01 (95{\%} CI −3E−5, 3E−2; P = 0.07). Mask acceptance score was significantly better in the midazolam group. There was no significant difference in emergence delirium scores between groups. Conclusion: This study demonstrates that zolpidem, as dosed, was similar to midazolam with regard to anxiety scoring, and inferior with regard to mask acceptance scores.",
keywords = "anesthesia, anti-anxiety agents, anxiety, emergence delirium, pediatric, preanesthetic medication",
author = "Hanna, {Amgad H.} and Davinder Ramsingh and Whitney Sullivan-Lewis and Sarah Cano and Patrick Leiter and Desiree Wallace and Gerald Andrews and Briahnna Austin and Applegate, {Richard Lee}",
year = "2018",
month = "1",
day = "1",
doi = "10.1111/pan.13501",
language = "English (US)",
journal = "Paediatric Anaesthesia",
issn = "1155-5645",
publisher = "Wiley-Blackwell",

}

TY - JOUR

T1 - A comparison of midazolam and zolpidem as oral premedication in children, a prospective randomized double-blinded clinical trial

AU - Hanna, Amgad H.

AU - Ramsingh, Davinder

AU - Sullivan-Lewis, Whitney

AU - Cano, Sarah

AU - Leiter, Patrick

AU - Wallace, Desiree

AU - Andrews, Gerald

AU - Austin, Briahnna

AU - Applegate, Richard Lee

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background: Anxiety associated with pediatric surgery can be stressful. Midazolam is a well-accepted anxiolytic in this setting. However, there are cases in which this medication is not effective. Zolpidem is a short-acting nonbenzodiazepine hypnotic drug that is administered orally and has quick onset of action (~15 minutes), and 2-3 hour duration. Aims: Based on the theory that impaired perception following oral zolpidem administration would suppress the development of anxiety, we sought to compare zolpidem to midazolam for pediatric preoperative anxiety. Methods: This prospective randomized double-blinded clinical trial was designed to compare the effectiveness of oral midazolam and zolpidem for anxiety premedication. Eighty ASA class I-II pediatric patients between 2 and 9 years old, surgery >2 hours, and at least 23 hours postoperative admission were included in the study. Randomization was done with 0.5 mg/kg midazolam or 0.25 mg/kg zolpidem administered orally. The primary outcome measure was between group difference in patient anxiety at the time of separation using the Modified Yale Preoperative Anxiety Scale. Secondary outcomes included emergence delirium and mask acceptance at induction. Results: There was no significant difference in Modified Yale Preoperative Anxiety Scale scores at separation between midazolam (median/interquartile range = 26.7/23.3-36.6) and zolpidem (median/interquartile range = 30.0/23.3-56.6) groups, difference 0.01 (95% CI −3E−5, 3E−2; P = 0.07). Mask acceptance score was significantly better in the midazolam group. There was no significant difference in emergence delirium scores between groups. Conclusion: This study demonstrates that zolpidem, as dosed, was similar to midazolam with regard to anxiety scoring, and inferior with regard to mask acceptance scores.

AB - Background: Anxiety associated with pediatric surgery can be stressful. Midazolam is a well-accepted anxiolytic in this setting. However, there are cases in which this medication is not effective. Zolpidem is a short-acting nonbenzodiazepine hypnotic drug that is administered orally and has quick onset of action (~15 minutes), and 2-3 hour duration. Aims: Based on the theory that impaired perception following oral zolpidem administration would suppress the development of anxiety, we sought to compare zolpidem to midazolam for pediatric preoperative anxiety. Methods: This prospective randomized double-blinded clinical trial was designed to compare the effectiveness of oral midazolam and zolpidem for anxiety premedication. Eighty ASA class I-II pediatric patients between 2 and 9 years old, surgery >2 hours, and at least 23 hours postoperative admission were included in the study. Randomization was done with 0.5 mg/kg midazolam or 0.25 mg/kg zolpidem administered orally. The primary outcome measure was between group difference in patient anxiety at the time of separation using the Modified Yale Preoperative Anxiety Scale. Secondary outcomes included emergence delirium and mask acceptance at induction. Results: There was no significant difference in Modified Yale Preoperative Anxiety Scale scores at separation between midazolam (median/interquartile range = 26.7/23.3-36.6) and zolpidem (median/interquartile range = 30.0/23.3-56.6) groups, difference 0.01 (95% CI −3E−5, 3E−2; P = 0.07). Mask acceptance score was significantly better in the midazolam group. There was no significant difference in emergence delirium scores between groups. Conclusion: This study demonstrates that zolpidem, as dosed, was similar to midazolam with regard to anxiety scoring, and inferior with regard to mask acceptance scores.

KW - anesthesia

KW - anti-anxiety agents

KW - anxiety

KW - emergence delirium

KW - pediatric

KW - preanesthetic medication

UR - http://www.scopus.com/inward/record.url?scp=85055119621&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85055119621&partnerID=8YFLogxK

U2 - 10.1111/pan.13501

DO - 10.1111/pan.13501

M3 - Article

JO - Paediatric Anaesthesia

JF - Paediatric Anaesthesia

SN - 1155-5645

ER -