Phase 4
N=63
Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
Strabismus · Delirium on Emergence · Pediatric Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01901588 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery — 50; 48 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine (Drug); Placebo (Other)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery |
50; 48 | — |
| SECONDARY Percentage of Participants Receiving Pain Medication |
50; 66 | — |
| SECONDARY Post-op Pain Interventions |
18; 30 | — |
| SECONDARY Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications |
0; 14 | — |
| SECONDARY Time to Arousal |
60; 40 | — |
| SECONDARY Time to PACU Discharge |
186; 173 | — |
Summary
This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01901588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.