Dexmedetomidine as a Sole Premedication for BMT Placement

NCT05903326 | Completed

• 1 other identifier: NemoursANES
• Study Type: observational
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Effect of Drug; Complication of Treatment

Keywords

Myringotomy Tube placement; Sedation and analgesia; Emergence delirium

Outcome Measures

Primary Outcomes (1)

• efficacy for pain and emergence delirium

  use of dexmedetomidine alone in preoperative period

  preoperative period

Study Arms (2)

traditional treatment group

patients receiving bilateral myringotomy tube placement with the use of midazolam and intraoperative ketorolac

New standard of care

patients receiving bilateral myringotomy tube placement with the use of dexmedetomidine alone

Other: Dexmedetomidine

Interventions

Dexmedetomidine OTHER

this was an observational study only based on a change of practice

New standard of care

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

healthy children between the ages of 6 months and 5 years who are undergoing BMT without any other procedure and not meeting any of the above exclusion criteria.

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.

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Related Publications (7)

• 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.

  PMID: 32209961 BACKGROUND

• 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.

  PMID: 32846947 BACKGROUND

• 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.

  PMID: 12760984 BACKGROUND

• 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.

  PMID: 28458577 RESULT

• 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.

  PMID: 31571684 RESULT

• 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.

  PMID: 28337075 RESULT

• 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):1090-4. doi: 10.1016/j.ijporl.2014.04.014. Epub 2014 Apr 16.

  PMID: 24814231 RESULT

MeSH Terms

Conditions

Agnosia; Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Delirium; Confusion; Postoperative Complications; Pathologic Processes; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: February 11, 2022
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)