IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures

Distal Radius Fracture Clinical Trial

Official title:

IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures. Timmons Z MD, Feudale B MD Children Presenting to the ED With Distal Forearm Extremity Fractures Often Require Re-alignment Under Conscious Sedation. The Objective of This Study is to Evaluate the Sedative, and Analgesic Effects of Intranasal (IN) Dexmedetomidine (DEX) Who Undergo Conscious Sedation for Reduction of Closed Distal Forearm Fractures When Compared to Those Receiving the Standard of Care Intravenous (IV) Ketamine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03466242
• Other study ID #: 17-193
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: March 1, 2018
• Last updated: March 8, 2018
• Start date: May 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: March 2018
• Source: Phoenix Children's Hospital
• Contact: Zebulon Timmons, MD
• Phone: 602-933-1910
• Email: ztimmons[@]phoenixchildrens.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the sedative, and analgesic effects of intranasal (IN) Dexmedetomidine (DEX) in children presenting to a Pediatric Emergency Department (PED) who undergo conscious sedation for reduction of closed distal forearm fractures when compared to those receiving intravenous (IV) Ketamine. The secondary objective is to compare each sedation technique for safety and procedural outcomes.

Description:

Distal Forearm fractures are often are displaced requiring conscious sedation for closed reduction in the Emergency Department. Our institution's current standard of care consists of IN Fentanyl for baseline control of pain, and for those fractures requiring reduction; typically IV Ketamine is utilized. Ketamine is typically well tolerated but is not without concerns including hypertension, vomiting, and the rare but serious complication of laryngospasm. Dexmedetomidine (DEX) offers a possible alternative to IV Ketamine. DEX has been used safely in the critical care setting for both pediatrics and adults. It has been well documented as being quite effective in sedation, amnesia and analgesia. Using IN DEX for PED procedural sedation has the potential to obviate the need for IV placement and may offer a better conscious sedation profile than Ketamine with respect to sedation, analgesia, and adverse outcomes.

Our overall project would be to assess the efficiency of IN DEX in comparison to IV Ketamine, for proper sedation and analgesic coverage for children undergoing closed reduction of distal forearm fractures.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:Verbal children aged 2-18 with a single extremity displaced forearm fracture requiring conscious sedation and reduction will be screened for enrollment.

Exclusion Criteria:

1. Under age 2 years old or patients > 18 years old

2. Multiple Fractures

3. Significant multisystem trauma

4. Glasgow Coma Scale (GCS < 15)

5. Complex fractures that aren't deemed reducible in ED

6. Reported Allergy to Alpha -2-agonists

7. Pregnancy

8. Intoxication

9. Baseline Hypotension as < 70mm Hg + 2 x age or < 90mm Hg for patients > 11 years of age

10. Patients with prior reductions attempted at outside facilities

11. Aberrant nasal anatomy that precludes IN medications

12. Chronic Health issues that can affect DEX metabolism

13. History of adverse reactions to anesthesia

14. Patients transferred from outside facilities

15. Open fractures

Related Conditions & MeSH terms

• Conscious Sedation
• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Drug:
• Dexmedetomidine
Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine
• Ketamine
Evaluate sedative and analgesic effects of Intravenous Ketamine

Locations

Country	Name	City	State
United States	Phoenix Children's Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (26)

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Li BL, Zhang N, Huang JX, Qiu QQ, Tian H, Ni J, Song XR, Yuen VM, Irwin MG. A comparison of intranasal dexmedetomidine for sedation in children administered either by atomiser or by drops. Anaesthesia. 2016 May;71(5):522-8. doi: 10.1111/anae.13407. Epub 2 — View Citation

Lightdale JR, Mitchell PD, Fredette ME, Mahoney LB, Zgleszewski SE, Scharff L, Fox VL. A Pilot Study of Ketamine versus Midazolam/Fentanyl Sedation in Children Undergoing GI Endoscopy. Int J Pediatr. 2011;2011:623710. doi: 10.1155/2011/623710. Epub 2011 M — View Citation

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Malhotra PU, Thakur S, Singhal P, Chauhan D, Jayam C, Sood R, Malhotra Y. Comparative evaluation of dexmedetomidine and midazolam-ketamine combination as sedative agents in pediatric dentistry: A double-blinded randomized controlled trial. Contemp Clin De — View Citation

Miller JW, Divanovic AA, Hossain MM, Mahmoud MA, Loepke AW. Dosing and efficacy of intranasal dexmedetomidine sedation for pediatric transthoracic echocardiography: a retrospective study. Can J Anaesth. 2016 Jul;63(7):834-41. doi: 10.1007/s12630-016-0617- — View Citation

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Reynolds J, Rogers A, Capehart S, Manyang P, Watcha MF. Retrospective Comparison of Intranasal Dexmedetomidine and Oral Chloral Hydrate for Sedated Auditory Brainstem Response Exams. Hosp Pediatr. 2016 Mar;6(3):166-71. doi: 10.1542/hpeds.2015-0152. — View Citation

Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan — View Citation

Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x — View Citation

Yuen VM, Hui TW, Irwin MG, Yao TJ, Wong GL, Yuen MK. Optimal timing for the administration of intranasal dexmedetomidine for premedication in children. Anaesthesia. 2010 Sep;65(9):922-9. doi: 10.1111/j.1365-2044.2010.06453.x. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the sedative effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine	The sedative effects of intranasal Dexmedetomidine will be compared to intravenous ketamine for conscious sedation via the Michigan Sedation Scoring (MSS) system.	12 months
Primary	Evaluate the analgesic effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine	The analgesic effects of intranasal Dexmedetomidine will be compared to intravenous ketamine for conscious sedation using either the Wong-Baker scale (FACES) or Visual Analogue Scale (VAS) depending on patient age and developmental status	12 months
Secondary	Compare each sedation technique for time to sedation onset	Time in minutes and seconds from administration of sedative agent until Michigan Sedation Scoring (MSS) is 3 or higher.	12 months
Secondary	Compare each sedation technique for length of sedation	Time in minutes and seconds from when Michigan Sedation Scoring (MSS) is 3 or higher until MSS is less than 3.	12 months
Secondary	Compare each sedation technique for length of ED stay	Time in minutes and seconds from presentation to ED to discharge	12 months
Secondary	Compare each sedation technique for need for additional doses of medications for analgesia or sedation	Will measure if any unplanned doses of sedatives or analgesics are required in either treatment arm.	12 months
Secondary	Compare each sedation technique for Vital sign abnormalities	Review vital signs following administration of either study drug to see if any vital signs were abnormal. Abnormal vital signs will be defined as hear rate, respiratory rate, or blood pressure above or below one standard deviation for age derived norms.	12 months
Secondary	Compare each sedation technique for need for respiratory interventions	Measure if any respiratory interventions were required during the patient's ED stay. Respiratory interventions defined as need for oxygen by any device.	12 months
Secondary	Compare each sedation technique for rate of vomiting	Describe the incidence (yes/no) of vomiting at any point after administration of either study drug to ED discharge.	12 months
Secondary	Compare each sedation technique for procedural success rate	Describe the successful reduction of orthopedic injuries in each study arm. Successful reduction defined as patient able to be discharged and not requiring admission, surgery, or secondary reduction attempts.	12 months
Secondary	Compare each sedation technique for patient family satisfaction	Describe the family satisfaction with each conscious sedation technique. Measured by brief survey given to the family upon consent for the study.	12 months