Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population

Conditions

• Enhanced Recovery After Surgery in a Pediatric Population

Eligibility Criteria

Sex

ALL

Age

3 Years - 12 Years

Healthy Volunteers

Accepted

Interventions

• Caffeine citrate 15mg/kg — DRUG
  Subjects will be randomized prior to surgery into one of the two study arms. One arm will receive 15mg/kg Caffeine citrate 15 minutes post surgery.
• 0.9% Sodium Citrate — DRUG
  Subjects will be randomized prior to surgery into one of the two study arms. One arm will receive 0.9% Sodium Citrate/kg 15 minutes post surgery.

Study Details

Dexmedetomidine (Dex), a selective α2-adrenergic receptor agonist, is the most used sedative for procedural sedation in children and in pediatric Intensive Care Unit (PICU) because it is associated with less respiratory depression and also less neurotoxicity; rather Dex appears neuroprotective. Unfortunately, Dex is associated with very long emergence times and may cause bradycardia and hypotension. However, using sedation dosing guidelines (by consensus among SPS members) 1-3 mcg/kg bolus and a 1-2 mcg/kg/hour infusion, hemodynamic compromise is less significant and rarely requires intervention in these patients. With this Dex sedation protocol, these pediatric patients usually take an average of 45 minutes (30-60 minutes) to wake and become alert and up to 2 hours to be discharged. Without reversal agents, emergence times from Dex sedation are slow. The prolonged recovery after Dex sedation for non-surgical procedures negatively affects throughput, thus increasing the cost of care. Patient safety and satisfaction suffer as a result. The children wake feeling tired and sluggish. The children don't feel back to normal for an extended period of time, which is not surprising given that the half-life for Dex metabolism in 2-3 hours in humans. However, using sedation dosing guidelines (by consensus among SPS members) 1-3 mcg/kg bolus and a 1-2 mcg/kg/hour infusion, hemodynamic compromise is less significant and rarely requires intervention in these patients. In humans, it has been found that caffeine at 7.5 mg/kg (15 mg caffeine citrate equivalent to 7.5 mg caffeine base) sped emergence from isoflurane anesthesia with minimal hemodynamic effects in healthy human volunteers. The goal of this clinical trial is to determine whether caffeine will facilitate the recovery of Dex sedation after a Magnetic Resonance Imaging (MRI) procedure by measuring the time from the end of Dex infusion to the time meeting the discharge criteria.

Key Dates

Start date

Sep 9, 2024

Status verified

Sep 2025

Primary completion

Jul 1, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dexmedetomidine +/- Caffeine Sedation
  Eligible subjects will be given 15 mg/kg caffeine citrate (equivalent to \~5 mg/ kg caffeine base) \~ 15 min after terminating Dex's infusion.
• Placebo Comparator: Dexmedetomidine +/- Placebo Sedation
  Eligible subjects will be given 9 mg/ml saline placebo) \~ 15 min after terminating Dex's infusion.

Primary Outcome Measure

Improve rate of wakefulness post surgery [ Time Frame: Up to 2 hours ]

Central Contacts

• Zheng Xie, MD, PhD
  773-702-2667
  [email protected]

Locations (1)

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