This trial is active, not recruiting.

Conditions strabismus, delirium on emergence, pediatric disorders
Treatments dexmedetomidine, placebo
Phase phase 4
Sponsor New York University School of Medicine
Start date March 2012
End date March 2014
Trial size 132 participants
Trial identifier NCT01901588, S12-00556


This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose prevention
dexmedetomidine Precedex
intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
(Placebo Comparator)
patients receive saline solution.
placebo saline solution
intraoperative dose of intravenous placebo

Primary Outcomes

Efficacy of Single-Shot Dexmedetomidine versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
time frame: two years

Secondary Outcomes

Post operative interventions
time frame: 4 hours after surgery

Eligibility Criteria

Male or female participants from 1 year up to 7 years old.

Inclusion Criteria: - ASA physical status of I or II - male or female, aged 1-7 - has no significant lab abnormalities Exclusion Criteria: - ASA physical status of III, IV or V - Presence of medicated behavioral disorder - Subjects for which dexmedetomidine, opiates, benzodiazepines or inhalational anesthetics are contraindicated. - Parental refusal

Additional Information

Official title Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
Principal investigator Jason Brown, MD
Description Emergence delirium (ED) is a complex behavioral disturbance characterized by psychomotor agitation, perceptual disturbances, delusions, and disorientation during recovery from general anesthesia. In the population of subjects who undergo strabismus surgery, there are multiple factors that may increase the risk of ED. These include age, typically preschool children aged 1-7 years, rapid surgical times with rapid awakening, use of sevoflurane as the primary anesthetic, and surgically-induced postoperative visual disturbance. The aims of this study are: 1) To examine whether post-induction treatment with an α-2 receptor agonist, precedex (dexmedetomidine), decreases postoperative emergence agitation after strabismus surgery compared to placebo, and 2) to determine whether treatment has any effect on postoperative pain, nausea/vomiting, number of pain-related interventions, and time to PACU discharge. We hypothesize that precedex will attenuate the ED response greater than placebo or a lower dose after strabismus surgery and will reduce PACU pain scores without increasing PACU length of stay. Inclusion: i. Pediatric patients aged 1-7 years of age ii. American Society of Anesthesiologists (ASA) physical status I-II iii. No significant laboratory abnormalities Exclusion: i. Presence of medicated behavioral disorder ii. Subjects for which precedex, opiates, benzodiazepines, or inhalational anesthetics are contraindicated iii. Parental refusal
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by New York University School of Medicine.