Dexmedetomidine to Treat Bariatric Surgery-associated Pain
Condition: Obesity
MeSH terms: Obesity
Intervention: Fentanyl; Morphine; Dexmedetomidine
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Morphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 12 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adolescent; Bariatric; Obesity; Pain; Opiate-sparing

Summary:

      Obesity represents one of the most important public health issues according to the World
      Health Organization and it has reached epidemic proportions globally. The prevalence of
      childhood obesity has rapidly increased over the past decade and is associated with multiple
      co-morbid disease states . It is estimated that approximately 15.5% of children and
      adolescents are obese with a body mass index of ≥95th percentile for age . This not only
      poses health concerns for the patient, but also places increased demands on our healthcare
      system that is already overwhelmed by burgeoning costs. Moreover, obese children and
      adolescents who maintain excessive weight as adults are predisposed to cardiovascular disease
      and premature death.

      In carefully selected patients who have failed to lose weight by diet and exercise, bariatric
      surgery provides an option to obtaining a healthy weight.

      It is increasingly becoming an attractive option, with the number of adolescents undergoing
      bariatric surgery in the United States tripling between 2000 and 2003.

      Obese patients are often afflicted with multi-organ dysfunction and obstructive sleep apnea,
      which presents unique challenges to the anesthesiologist managing their perioperative care .
      Bariatric surgery in obese adolescents may be associated with significant postoperative pain.
      Potent intravenous opioids such as fentanyl and morphine are at the mainstay of perioperative
      pain management. Unfortunately, respiratory depression and airway obstruction can often occur
      following administration of opioids in obese patients . This makes providing a safe analgesic
      regimen difficult during the perioperative setting. As opioids can be associated with
      respiratory depression and upper airway obstruction, surgeons and anesthesiologists alike
      must reconcile the adequacy of pain control with the risk of respiratory complications after
      surgery in obese adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI ≥ 95th percentile.

          -  Hospitalized overnight after surgery

        Exclusion Criteria:

          -  History or a family (parent or sibling) history of malignant hyperthermia

          -  Renal or hepatic disorders

          -  Allergy to opioid analgesics

          -  An allergy to α2-adrenergic agonists or sulfa drugs

          -  Uncontrolled hypertension

          -  Clinically significant neurologic diseases

          -  Pregnancy or lactating female