Effect of Drug Clinical Trial
— BMTOfficial title:
Dexmedetomidine as a Sole Premedication for BMT Placement in Children Undergoing Bilateral Myringotomy Tube Placement Surgery
Verified date | June 2023 |
Source | Nemours Children's Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 276 |
Est. completion date | February 3, 2023 |
Est. primary completion date | February 3, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 6 Months to 5 Years |
Eligibility | Inclusion Criteria: - healthy children between the ages of 6 months and 5 years who have had bilateral myringotomy tube placement without any other surgical procedures. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Nemours Alfred I duPont Hospital for Children | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
Nemours Children's Clinic |
United States,
Behrle N, Birisci E, Anderson J, Schroeder S, Dalabih A. Intranasal Dexmedetomidine as a Sedative for Pediatric Procedural Sedation. J Pediatr Pharmacol Ther. 2017 Jan-Feb;22(1):4-8. doi: 10.5863/1551-6776-22.1.4. — View Citation
Dave NM. Premedication and Induction of Anaesthesia in paediatric patients. Indian J Anaesth. 2019 Sep;63(9):713-720. doi: 10.4103/ija.IJA_491_19. — View Citation
Dewhirst E, Fedel G, Raman V, Rice J, Barry N, Jatana KR, Elmaraghy C, Merz M, Tobias JD. Pain management following myringotomy and tube placement: intranasal dexmedetomidine versus intranasal fentanyl. Int J Pediatr Otorhinolaryngol. 2014 Jul;78(7):1090- — View Citation
Lee SJ, Sung TY. Emergence agitation: current knowledge and unresolved questions. Korean J Anesthesiol. 2020 Dec;73(6):471-485. doi: 10.4097/kja.20097. Epub 2020 Mar 25. — View Citation
Mahmoud M, Barbi E, Mason KP. Dexmedetomidine: What's New for Pediatrics? A Narrative Review. J Clin Med. 2020 Aug 24;9(9):2724. doi: 10.3390/jcm9092724. — View Citation
Pappas AL, Fluder EM, Creech S, Hotaling A, Park A. Postoperative analgesia in children undergoing myringotomy and placement equalization tubes in ambulatory surgery. Anesth Analg. 2003 Jun;96(6):1621-1624. doi: 10.1213/01.ANE.0000064206.51296.1D. — View Citation
Robinson H, Engelhardt T. Ambulatory anesthetic care in children undergoing myringotomy and tube placement: current perspectives. Local Reg Anesth. 2017 Apr 19;10:41-49. doi: 10.2147/LRA.S113591. eCollection 2017. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | efficacy for pain and emergence delirium | use of dexmedetomidine alone in preoperative period | preoperative period |
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