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NCT05903326: BMT

Dexmedetomidine as a Sole Premedication for BMT Placement

Completed Last updated 18 June 2023
What this trial tests

trial testing Dexmedetomidine in Effect of Drug in 276 participants. Completed in 3 February 2023.

Timeline
11 February 2022
Primary endpoint
3 February 2023
3 February 2023

Quick facts

Lead sponsorNemours Children's Clinic
StatusCompleted
Study typeOBSERVATIONAL
Enrollment276
Start date11 February 2022
Primary completion3 February 2023
Estimated completion3 February 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Nemours Children's Clinic

Who can join

Adults 6 Months to 5, any sex, with Effect of Drug or Complication of Treatment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is very little evidence or research documenting any single method of sedation/analgesia for myringotomy tube (BMT) placement as being more effective than others. This was a retrospective chart review conducted to determine if there were significant differences in efficacy of administered pre-operative Midazolam and Intraoperative IM Ketorolac (traditional) vs. pre-operative Dexmedetomidine alone for pain and emergence delirium management of children undergoing placement of BMTs. The current protocol was changed under the direction of anesthesia and team members who wanted to see what the outcomes of the new management plan were. The plan was a prospective chart review and for this project, 276 patient charts were reviewed, 154 patients received traditional anesthesia treatment and 122 received Precedex. Data analysis indicated that the patients who had received Dexmedetomidine had significantly higher FLACC scores (meaning better pain control) than those who received the traditional therapy. There was no difference in emergence delirium between the two groups.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Dexmedetomidine

Trials testing the same drug.

Other recruiting trials for Effect of Drug

Currently open trials in the same condition.

Other Nemours Children's Clinic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05903326.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing