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COMPLETED Phase 4

Dexmedetomidine in Pediatric Tonsillectomy

NCT01057381 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Dexmedetomidine 0.75 mcg/kg
  • DRUG Morphine 50 mcg/kg
  • DRUG Morphine 100 mcg/kg
  • DRUG Dexmedetomidine 1 mcg/kg

Study Locations (1)

Texas

  • Texas Children's Hospital, Baylor College of Medicine — Houston

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2005-08
Est. Completion 2010-12
Phase Phase 4

Sponsor

Baylor College of Medicine

678 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01057381

The ClinicalTrials.gov registry entry for NCT01057381 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 678 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Post Operative Analgesia appearing as the primary indexed condition, and to 4 interventions — of which Dexmedetomidine 0.75 mcg/kg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01057381 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01057381 about?

NCT01057381 is a clinical study titled "Dexmedetomidine in Pediatric Tonsillectomy". 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.

What is the current status of trial NCT01057381?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 109 participants. The study started on 2005-08. Estimated completion is 2010-12.

What conditions does trial NCT01057381 study?

This clinical trial studies the following conditions: Post Operative Analgesia, Pediatric Adenotonsillectomy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01057381?

The interventions under investigation include: Dexmedetomidine 0.75 mcg/kg (DRUG), Morphine 50 mcg/kg (DRUG), Morphine 100 mcg/kg (DRUG), Dexmedetomidine 1 mcg/kg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01057381?

This trial is sponsored by Baylor College of Medicine, which has 678 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01057381 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial