Phase 4
N=106
Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease
Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT02222246 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Difference in Pain Score as Measured by a Visual Analogue Scale (VAS) — 26.4; 43.0 Units on a 100 mm VAS — p=0.0311
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hydromorphone (Standardized, weight-based dosing) (Drug); Morphine Sulfate (Standardized, weight-based dosing) (Drug); Hydromorphone (Patient Specific dosing) (Drug); Morphine Sulfate (Patient Specific dosing) (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Pain Score as Measured by a Visual Analogue Scale (VAS) |
26.4; 43.0 | 0.0311 sig |
| SECONDARY Change in Pain Visual Analogue Scale (VAS) Scores Over Time |
82.2; 82.2; 80.6; 79.6; 79.0; 77.2 | 0.0049 sig |
| SECONDARY Incidence of Nausea During Emergency Department Visits |
26; 46; 38; 16 | 0.0001 sig |
| SECONDARY Incidence of Vomiting During Emergency Department Visits |
54; 54; 10; 8 | 0.6625 |
| SECONDARY Incidence of a Decrease in Systolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit |
55; 56; 9; 6 | 0.4473 |
| SECONDARY Incidence of a Decrease in Diastolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit |
40; 42; 24; 20 | 0.5372 |
| SECONDARY Incidence of Oxygen Desaturation (< 95%) (YES) During Emergency Department Visit |
27; 32; 37; 30 | 0.2891 |
| SECONDARY Incidence of Respiratory Distress (YES) During Emergency Department Visit |
64; 62; 0; 0 | — |
| SECONDARY Incidence of Sedation During Emergency Department Visit |
51; 53; 13; 9 | 0.3915 |
| SECONDARY Incidence of the Need for Supplemental Oxygen During Emergency Department Visit |
49; 55; 15; 7 | 0.0726 |
| SECONDARY Incidence of the Administration of Naloxone During Emergency Department Visit |
64; 62; 0; 0 | — |
| SECONDARY Incidence of the Need for Assistive Ventilation |
64; 62; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adult SCD patients with genotypes SS, SC, SB+, or SB-
Exclusion Criteria
- Patients with sickle cell trait
- Allergic to both morphine sulfate and hydromorphone,
- Patients who have an explicit care plan that states they cannot be admitted to the hospital for pain control,
- Non-English speaking,
- Patients admitted for a medical complication,
- Record of >24 ED visits in the prior 12 months,
- Children
Data sourced from ClinicalTrials.gov (NCT02222246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.