Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05903326
Other study ID # NemoursANES
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04549012 - Determination of Blood Loss After CS Early Phase 1
Active, not recruiting NCT06114758 - Comparison Effectiveness of Rectal Misoprostol & Intravenous Tranexamic Acid Reducing Hemorrhage in Myomectomy
Completed NCT05076253 - Efficacy of Ivermectin in COVID-19 Phase 1/Phase 2
Recruiting NCT04573049 - The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement Phase 4
Not yet recruiting NCT04562493 - Comparative Effect of Transforaminal Injection of Magnesium Sulphate Versus Ozone Therapy on Oxidative Stress Biomarkers in Lumbar Disc Related Radicular Pain N/A
Completed NCT04762147 - Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy Phase 3
Completed NCT06432309 - Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease N/A
Not yet recruiting NCT05510986 - The Effect of Oxycodone Hydrochloride on CRBD After TURBT Under General Anesthesia N/A
Recruiting NCT05092074 - Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) for Patients With Hepatitis C Virus Infection
Recruiting NCT05968885 - Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity Phase 4
Recruiting NCT05595044 - Effect of Vitamin D Therapy in Autism Spectrum Disorder Phase 1
Not yet recruiting NCT06100510 - PFA 100 Evaluation and Reference Interval HOACNY Phase 4
Completed NCT05060913 - Emla Cream Versus Benzocaine on Analgesia Early Phase 1
Not yet recruiting NCT05293119 - Role of Tofacitinib in Vitiligo Patients Early Phase 1
Not yet recruiting NCT06414018 - Effect of Equivalent Dose Sufentanil and Afentanil in Bronchoscopic Treatment N/A
Recruiting NCT05786859 - The Efficacy and Safety of Rifaximin Treatment Early Phase 1
Not yet recruiting NCT06290219 - The Effect of Platelet-rich Plasma Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction Phase 3
Completed NCT05277480 - Apatinib With Ifosfamide Plus Etoposide for Relapsed or Refractory Osteosarcoma (OAIE) Phase 2
Recruiting NCT05482451 - Nivolumab and All-trans Retinoic Acid for Pancreatic Cancer Early Phase 1
Not yet recruiting NCT04892212 - Sirolimus in Treatment of Proteinuric Flares of Lupus Nephritis Phase 2/Phase 3