Effect of DrugBMTNCT05903326
Dexmedetomidine as a Sole Premedication for BMT Placement
An observational study of Effect of Drug and Complication of Treatment, run by Nemours Children's Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Effect of Drug, Complication of Treatment
- What is being tested?
- Dexmedetomidine
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2022to 3 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- Child
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.
Who may be able to join
- healthy children between the ages of 6 months and 5 years who have had bilateral myringotomy tube placement without any other surgical procedures.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: 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.
Read the 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.
- Conditions
- Effect of Drug, Complication of Treatment
- Being tested
- Dexmedetomidine
- Keywords
- Myringotomy Tube placement, Sedation and analgesia, Emergence delirium
- Medical subject headings
- Agnosia, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineOther
this was an observational study only based on a change of practice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy for pain and emergence delirium
use of dexmedetomidine alone in preoperative period
Measured: preoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start11 Feb 2022
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903326
- Sponsor's protocol ID
- NemoursANES
- Acronym
- BMT
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data included retrospective chart review, with patients de-identified and coded upon completion of record-keeping. Data will be shared in aggregate format.
Publications
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.
PubMed 32209961Mahmoud 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.
PubMed 32846947Pappas 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.
PubMed 12760984Robinson 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.
PubMed 28458577Dave 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.
PubMed 31571684Behrle 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.
PubMed 28337075Dewhirst 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.
PubMed 24814231
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine as a Sole Premedication for BMT Placement in Children Undergoing Bilateral Myringotomy Tube Placement Surgery
- ClinicalTrials.gov ID
- NCT05903326
- Acronym / sponsor ID
- BMT / NemoursANES
- Conditions
- Effect of Drug, Complication of Treatment
- Keywords
- Myringotomy Tube placement, Sedation and analgesia, Emergence delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional treatment group | – | –patients receiving bilateral myringotomy tube placement with the use of midazolam and intraoperative ketorolac |
| New standard of care | – | Other: Dexmedetomidinepatients receiving bilateral myringotomy tube placement with the use of dexmedetomidine alone |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- healthy children between the ages of 6 months and 5 years who have had bilateral myringotomy tube placement without any other surgical procedures.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidinethis was an observational study only based on a change of practice | Other | New standard of care |
Primary outcome
efficacy for pain and emergence delirium
Time frame: preoperative period
use of dexmedetomidine alone in preoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 32209961Lee 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.
- Background: PubMed 32846947Mahmoud 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.
- Background: PubMed 12760984Pappas 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.
- Results publication: PubMed 28458577Robinson 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.
- Results publication: PubMed 31571684Dave 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.
- Results publication: PubMed 28337075Behrle 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.
- Results publication: PubMed 24814231Dewhirst 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.
- Individual participant dataSharing planned: No. Data included retrospective chart review, with patients de-identified and coded upon completion of record-keeping. Data will be shared in aggregate format.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effect of Drug and Complication of Treatment, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy for pain and emergence delirium (time frame: preoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05903326, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.