Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans

Keywords

• procedural sedation
• dexmedetomidine
• propofol
• MRI

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Eligibility criteria

Study arms

• Experimental
  dexmedetomidine low dose group

  low dose of dexmedetomidine to be given

  Drug: dexmedetomidine · Drug: propofol

• Experimental
  dexmedetomidine middle dose group

  middle dose of dexmedetomidine to be given

  Drug: dexmedetomidine · Drug: propofol

• Experimental
  dexmedetomidine high dose group

  high dose of dexmedetomidine to be given

  Drug: dexmedetomidine · Drug: propofol

Interventions

• Drugdexmedetomidine

  dexmedetomidine low, middle and high doses are provided as an intravenous bolus loading dose followed by an intravenous maintenance dose infusion throughout the MRI scan

• Drugpropofol

  propofol IV administration will be given if needed to maintain sedation

Primary outcomes

1. Percentage of Participants at the DEX High Dose Versus Low Dose in the Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI

   Percentage of participants who did not require PRO to complete MRI scan in the combined age cohorts are reported in this outcome measure.

   Time frame: Up to maximum of 3 hours during MRI scan on Day 1

Secondary outcomes

1. Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI

   Percentage of participants who did not require PRO to complete MRI scan in each age cohort are reported in this outcome measure.

   Time frame: Up to maximum of 3 hours during MRI scan on Day 1

2. Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI

   Percentage of participants who did not require PRO to complete MRI scan in each age cohort and combined age cohorts are reported in this outcome measure.

   Time frame: Up to maximum of 3 hours during MRI scan on Day 1

3. Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age

   In this outcome measure percentage of time for which participant had maintained PSSS score of 2 was reported. PSSS score ranges from 0 to 5, where 0= sedation with abnormal physiologic parameters requiring acute intervention, 1= sedation with normal vital signs, but requiring airway intervention, 2= no movement during procedure, no frown, no verbalization of complaint indicating no pain and anxiety, 3= no movement during procedure but expression of pain and anxiety on face, verbalization of complaint, requiring help positioning, 4= movement during procedure requiring gentle immobilization for positioning, verbalization of some discomfort or stress, but no crying or shouting that expresses stress or objection, 5= movement impeding proceduralist and requiring forceful immobilization, crying or shouting during procedure, but vocalization not required. Higher score indicated less sedation.

   Time frame: Up to maximum of 3 hours during MRI scan on Day 1

4. Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age

   Participants who did not have PRO administered were censored.

   Time frame: Up to maximum of 3 hours during MRI scan on Day 1

5. Emergence Time - By Age Cohort and Combined Age

   Emergence time: time from the end of the MRI scan to when the participant met a Modified Aldrete score \>=9. Participants who were withdrawn or discharged without reaching a Modified Aldrete score \>=9, were censored, time computed from end of MRI scan to time of the last clinical assessment (vital signs). Zero minute was used as the censored time if no vital signs were taken during the post-MRI recovery period. Modified Aldrete score: validated observational medical scoring system that allowed verbal prompts for the measurement of recovery after anesthesia (post anesthesia) which included items: activity, respiration, circulation, consciousness, and oxygenation. Each item was scored from 0 to 2, higher scores signified better recovery. The scores of each item were summed to obtain a total score of 0 to 10, where higher scores indicated well recovered participant post anesthesia.

   Time frame: Post MRI scan on Day 1 up to 24 hours

6. Number of Participants Who Received PRO - By Age Cohort and Combined Age

   Time frame: Up to maximum of 3 hours during MRI scan on Day 1

7. Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age

   Time frame: Up to maximum of 3 hours during MRI scan on Day 1

8. Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age

   Time frame: Up to maximum of 3 hours during MRI scan on Day 1

Baseline characteristics

Study documents

• Study protocol · Mar 11, 2021
• Statistical analysis plan · Jun 9, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.