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Dexmedetomidine to Treat Bariatric Surgery-associated Pain

NCT02880540 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-12-07

Study results available
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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.

Conditions

Interventions

DRUG

Fentanyl

DRUG

Morphine

DRUG

Dexmedetomidine

Sponsors & Collaborators

  • Janelle Vaughns

    lead OTHER

Principal Investigators

  • Celeste Martin, MD · Childrens National Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02880540 on ClinicalTrials.gov