Overview

This trial is active, not recruiting.

Conditions pain, sickle cell disease
Treatments morphine, nubain
Phase phase 3
Sponsor Children's Healthcare of Atlanta
Collaborator Atlanta Clinical and Translational Science Institute
Start date May 2010
End date January 2014
Trial size 250 participants
Trial identifier NCT01380197, 09-076

Summary

The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes are thought to result from ischemia caused when small blood vessels are occluded by misshapen, inflexible erythrocytes. Painful episodes are the most common cause of hospitalization, morbidity, and impairment for SCD patients. There is no therapy that completely prevents or directly aborts painful events for all patients. Consequently, treatment for acute VOC is primarily supportive using hydration and medicinal pain control. Every pain medication has the potential to relieve pain but is associated with significant limitations and side effects.

The primary hypothesis to be tested in this double blind, randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome. The investigators also expect subjects will report fewer side effects from respiratory depression, abdominal distention from reduced peristalsis, reduced histamine release causing pruritis and still be provided adequate pain control. Further hypotheses to be tested is ability to recruit patient participants while being treated in the Emergency Department and that continuous infusion of Nalbuphine with accompanying patient controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total opiates consumption, while decreasing length of hospitalization.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis
morphine
Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled. Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).
(Active Comparator)
Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients
nubain
Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled. Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).

Primary Outcomes

Measure
Acute Chest Syndrome
time frame: 3 days

Secondary Outcomes

Measure
Pain relief
time frame: 2 days

Eligibility Criteria

Male or female participants from 6 years up to 19 years old.

Inclusion Criteria: - Patients with sickle cell disease (SS, SC, SβThal) who are hospitalized for acute painful episodes - 6 years old and < 19 years old - Normal baseline chest radiograph - Normal renal and hepatic function within the previous 12 months Exclusion Criteria: - Previous patient participation in this clinical trial - Any patient on chronic transfusion Any patient with pulmonary infiltrate on chest radiograph on admission - Any patient with DSM diagnosis, excluding those with Attention Deficit Disorder, on or off treatment - Any patient with documented allergy to either study drug - Any patient with known evidence of an underlying disease that would interfere with evaluation of a therapeutic response such as: - Hepatic dysfunction (3x ALT), - Renal dysfunction (Cr > 1 children/adolescents, Cr >2 adults), - Pulmonary Hypertension (TRJ >3.0), - Cardiac dysfunction. - Any patient with symptoms of an acute stroke. - Any patient known or suspected to be pregnant. - Any patient with priapism - The patient or guardian who will not give consent or assent to be randomized.

Additional Information

Official title Choosing Opioid Management for Pain and Analyzing ACS Rates Equally
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Children's Healthcare of Atlanta.