Clinical trial NCT05903326: Dexmedetomidine as a Sole Premedication for BMT Placement
Official title: Dexmedetomidine as a Sole Premedication for BMT Placement in Children Undergoing Bilateral Myringotomy Tube Placement Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effect of Drug
Complication of Treatment
Keywords: Myringotomy Tube placement
Sedation and analgesia
Emergence delirium
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 276
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: efficacy for pain and emergence delirium
timeFrame: preoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Alfred I duPont Hospital for Children
state: Delaware
Study officials:
References:
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