title: A single dose of fentanyl and midazolam prior to Cesarean section have no adverse neonatal effects.
abstract: OBJECTIVE
  Analgesia and sedation, routinely used as adjunct medications for regional anesthesia, are rarely used in the pregnant patient because of concerns about adverse neonatal effects. In an effort to obtain more information about maternal analgesia and sedation we studied neonatal and maternal effects of iv fentanyl and midazolam prior to spinal anesthesia for elective Cesarean section.
  
  
  METHODS
  In this double-blinded, randomized, placebo-controlled trial, 60 healthy women received either a combination of 1 microg x kg(-1) fentanyl and 0.02 mg x kg(-1) midazolam intravenously or an equal volume of iv saline at the time of their skin preparation for a bupivacaine spinal anesthetic. Sample size was based on a non-parametric power analysis (power > 0.80 and alpha = 0.05) for clinically important differences in Apgar scores. Fetal outcome measures included Apgar scores, continuous pulse oximetry for three hours, and neurobehavioural scores. Maternal outcomes included catecholamine levels, and recall of anesthesia and delivery.
  
  
  RESULTS
  There were no between-group differences of neonatal outcome variables (Apgar score, neurobehavioural scores, continuous oxygen saturation). Mothers in both groups showed no difference in their ability to recall the birth of their babies.
  
  
  CONCLUSIONS
  Maternal analgesia and sedation with fentanyl (1 microg x kg(-1)) and midazolam (0.02 mg x kg(-1)) immediately prior to spinal anesthesia is not associated with adverse neonatal effects.
authors.affiliation: Department of Anesthesiology, University of Alabama at Birmingham, 619 South 19th Street, Birmingham, AL 35249-6810, USA. froelich@uab.edu
authors.forename: Michael A
authors.initials: MA
authors.lastname: Frölich
authors.forename: David J
authors.initials: DJ
authors.lastname: Burchfield
authors.forename: Tammy Y
authors.initials: TY
authors.lastname: Euliano
authors.forename: Donald
authors.initials: D
authors.lastname: Caton
mesh_terms: D000328:Adult; D000701:Analgesics, Opioid / Q000009:adverse effects* / Q000627:therapeutic use; D000775:Anesthesia, Spinal / Q000379:methods; D000779:Anesthetics, Local / Q000008:administration & dosage; D014151:Anti-Anxiety Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001034:Apgar Score; D002045:Bupivacaine / Q000008:administration & dosage; D002395:Catecholamines / Q000097:blood; D002585:Cesarean Section / Q000379:methods*; D004359:Drug Therapy, Combination; D005260:Female; D005283:Fentanyl / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D007231:Infant, Newborn / Q000502:physiology*; D011939:Mental Recall / Q000187:drug effects; D008874:Midazolam / Q000009:adverse effects* / Q000627:therapeutic use; D010092:Oximetry / Q000379:methods; D011247:Pregnancy; D011446:Prospective Studies; D012016:Reference Values
chemical_list: D000701:Analgesics, Opioid; D000779:Anesthetics, Local; D014151:Anti-Anxiety Agents; D002395:Catecholamines; D008874:Midazolam; D005283:Fentanyl; D002045:Bupivacaine