Dexmedetomidine as a Sole Premedication for BMT Placement (BMT)

June 16, 2023 updated by: Nemours Children's Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

276

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours Alfred I duPont Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
this was an observational study only based on a change of practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy for pain and emergence delirium
Time Frame: preoperative period
use of dexmedetomidine alone in preoperative period
preoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2022

Primary Completion (Actual)

February 3, 2023

Study Completion (Actual)

February 3, 2023

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NemoursANES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data included retrospective chart review, with patients de-identified and coded upon completion of record-keeping. Data will be shared in aggregate format.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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