Dexmedetomidine as a Sole Premedication for BMT Placement

Completed

Conditions studied: Effect of Drug, Complication of Treatment

In brief

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.

Key facts

Study ID

NCT05903326

Run by

Nemours Children's Clinic

People needed

276

Starts

2022-02-11

Expected to finish

2023-02-03

Last updated by the study team

2023-06-18

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• healthy children between the ages of 6 months and 5 years who have had bilateral myringotomy tube placement without any other surgical procedures.

You may not qualify if…

• children who present for BMT coupled with other procedures
• children with coagulation disorders
• children with allergies to ketorolac or dexmedetomidine,
• ASA physical status classification greater than 2,
• children with sensory processing disorders and/or autism spectrum disorders or other emotional/behavioral problems which may affect pain scores or responses,
• children who undergoing placement of Triune myringotomy tubes
• children with medical conditions who would be at risk related to anesthesia or the surgical procedures itself.

Where it is running

• Nemours Alfred I duPont Hospital for Children — Wilmington, Delaware, United States

Full record on ClinicalTrials.gov

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