Dexmedetomidine as a Sole Premedication for BMT Placement

Effect of Drug Clinical Trial

— BMT  

Official title:

Dexmedetomidine as a Sole Premedication for BMT Placement in Children Undergoing Bilateral Myringotomy Tube Placement Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05903326
• Other study ID #: NemoursANES
• Status: Completed
• Start date: February 11, 2022
• Est. completion date: February 3, 2023

Study information

• Verified date: June 2023
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Bilateral myringotomy tube placement (BMT) is one of the most frequently performed pediatric ENT surgeries. Ensuring adequate analgesia and anxiolysis during the perioperative period is essential, as agitation in children can lead to emotional distress for children and parents and can lead to complications such as injury and post-traumatic stress disorders. Premedication is vital for anxiolysis, as it can facilitate anesthesia induction by reducing agitation, enhancing cooperation, and minimizing fear, anxiety, and physical resistance during critical perioperative events such as parental separation, venipuncture, or mask application.

Standard perioperative analgesia and anxiolytic protocols for BMT vary by institution. Since the procedure is often performed without intravenous access, non-parental routes of administration are frequently used for both preoperative anxiolytic control and intraoperative analgesia. The popular perioperative analgesia regimen consists of intramuscular ketorolac, preceded by nasal midazolam before surgery for anxiolytic control. Midazolam is widely used as a pre-anesthetic medication due to its ability to reduce anxiety and ease parental separation fears while minimizing delay in discharge. Dexmedetomidine (Dex), an alternative medication with sedative and analgesic properties, has gained attention for its potential use in pediatric anesthesiology both for premedication and perioperative analgesia.

This study explored the efficacy of using preoperative intranasal dexmedetomidine as the sole alternative for providing both anxiolysis and perioperative analgesia compared to standard treatment. We aim to evaluate the efficacy and safety of dexmedetomidine as a premedication agent in pediatric patients undergoing BMT, potentially streamlining anesthetic protocols and enhancing the overall experience for pediatric patients, families, and perioperative clinical teams.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: February 3, 2023
• Est. primary completion date: February 3, 2023
• 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.

Related Conditions & MeSH terms

• Complication of Treatment
• Effect of Drug

Intervention

Other:
• Dexmedetomidine
this was an observational study only based on a change of practice

Locations

Country	Name	City	State
United States	Nemours Alfred I duPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

References & Publications (7)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy for pain and emergence delirium	use of dexmedetomidine alone in preoperative period	preoperative period