CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 106 enrolled
Drug / intervention
Hydromorphone (Standardized, weight-based dosing) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02222246
NCT02222246Phase 4Completed

Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease

Duke University·interventional·Posted Aug 21, 2014·Updated Aug 4, 2017

In Brief

A Phase 4 clinical trial evaluating Hydromorphone (Standardized, weight-based dosing), Morphine Sulfate (Standardized, weight-based dosing), and 2 other interventions for Sickle Cell Disease. Completed, enrolled 106 participants across 2 sites.

Detailed Summary

The goal of this pilot study is to improve emergency department (ED) pain management for adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic disorder in the United States, and occurs primarily among African Americans. Management of painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the most common reason for SCD patients to visit the ED. Currently, there is no standard approach to managing VOC pain in the ED that is widely accepted and used, and pain management for vaso-occlusive crisis in persons with SCD is very different between providers and not based on research. Many times, patients who come to the ED with sickle cell pain feel that they do not receive adequate pain control. If EDs could provide efficient, effective, safe, patient-centered analgesic management, it may be possible to improve pain management for adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive crises caused by sickle cell disease will soon be published by the National Heart, Lung and Blood Institute of the National Institutes of Health. These guidelines recommend patient-specific pain treatment protocols or a standardized pain management protocol for SCD when a patient does not already have a pain treatment protocol designed for them. The purpose of this pilot study is to compare these two ways to treat vaso-occlusive pain in the ED for adults with sickle cell disease, and to determine if a large randomized controlled trial is feasible and required.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 21, 2014
Enrollment StartMar 15, 2015
Primary CompletionMay 31, 2016
Study CompletionJun 30, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.9 years ago

Interventions

Hydromorphone (Standardized, weight-based dosing)drug

Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).

Morphine Sulfate (Standardized, weight-based dosing)drug

Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).

Hydromorphone (Patient Specific dosing)drug

Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.

Morphine Sulfate (Patient Specific dosing)drug

Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.