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Phase 4 Completed N=109 Randomized Quadruple-blind Treatment

Dexmedetomidine in Pediatric Tonsillectomy

Pediatric Adenotonsillectomy · Post Operative Analgesia
Source: ClinicalTrials.gov NCT01057381 ↗
Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Amount of Post-Operative Rescue Morphine Required for Analgesia — 45.2; 37.0; 43.3; 36.5 ug/kg
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy.

Outcome Measures

OutcomeResultp-value
PRIMARY
Amount of Post-Operative Rescue Morphine Required for Analgesia
45.2; 37.0; 43.3; 36.5
SECONDARY
Morphine Rescue Doses Needed by Participants
6; 3; 1; 4; 2; 14
SECONDARY
Duration of Oxygen Supplementation
17; 19; 20; 18
SECONDARY
Time to PACU Discharge Readiness
115; 116; 117; 122
SECONDARY
Number of Participants With Emergence Agitation
5; 4; 4; 1
SECONDARY
Number of Participants With Postoperative Complications
2; 0; 0; 3; 0; 0

Eligibility Criteria

Inclusion Criteria

  • Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.

Exclusion Criteria

  • Children less than 3 years
  • Children with uncorrected cardiac lesions
  • Children with heart block or liver impairment
  • Children with American Society of Anesthesiology Class 3 or 4.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01057381). 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. Informational only — not medical advice.

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