Hyperbaric Oxygen Therapy in Sickle Cell Pain
- Conditions
- Vaso-occlusive CrisisSickle Cell Anemia Crisis
- Interventions
- Device: hyperbaric oxygen therapy
- Registration Number
- NCT03412045
- Lead Sponsor
- University of Nebraska
- Brief Summary
Sickle cell anemia is a genetic blood disorder where red blood cells are abnormally shaped, crescent- or sickle-shaped, instead of the normal, round shape. This misshapen cell is rigid and sticky, causing them to clump together and block small blood vessels. This blockage can lead to pain, infections, and organ damage, and the shortened lifespan of sickle cells causes anemia. The purpose of this study is to explore if hyperbaric oxygen (HBO) therapy would decrease pain and hospital length of stay associated with acute sickle cell pain crisis. Adults presenting with an uncomplicated acute pain crisis (i.e., acute chest syndrome, acute myocardial infarction/stroke) would be eligible. The intervention would be 1-3 hyperbaric oxygen sessions depending on response to therapy. Each treatment session will be approximately two hours in length. Evaluation would be through participants' self--assessment via the visual analog scale for pain level before and after treatments as well as tracking length of stay in the hospital.
- Detailed Description
Sickle cell anemia is a genetic blood disorder where red blood cells are abnormally shaped, crescent- or sickle-shaped, instead of the normal, round shape. This misshapen cell is rigid and sticky, causing them to clump together and block small blood vessels. This blockage can lead to pain, infections, and organ damage, and the shortened lifespan of sickle cells causes anemia. Previous study suggest that hyperbaric oxygen (HBO) may help ameliorate symptoms and have positive effects for sickle cell patients. In addition, although a few studies did discuss pain reduction associated with HBO therapy, results are conflicting, and sample sizes are too small to carry any weight when compared against each other. No information has been gathered to date about how HBO therapy this may affect hospital length of stay. The purpose of this study is to determine if HBO treatment in participants experiencing sickle cell crisis would produce a decrease in pain and decrease in hospital length of stay.
Current standard of care at University of Nebraska Medical Center (UNMC) and Nebraska Medicine for patients identified as having sickle cell and experiencing an uncomplicated pain crisis that is not responding to acute treatment in the emergency department over the course of a few hours is to admit the patient to the hematology service. They would receive IV fluid administration, oxygen, and usually large doses of pain medications, until their pain subsides. Patient's complete blood count (CBC) and comprehensive metabolic panel (CMP) are monitored during this time for acute changes. Once pain has subsided and no signs of complications such as infection, etc. are found, the patient is discharged with follow up in hematology clinic.
Interventions would be 1-3 hyperbaric oxygen sessions depending on response to the therapy. Each treatment session will be approximately two hours in length. Evaluation would be through participants' self-assessment via the visual analog scale for pain level before and after treatments as well as tracking length of stay in the hospital. Changes in pain ratings will use the visual pain scale of 0 to 100, where 0 is no pain and 100 being maximal pain imaginable for that participant. Pain ratings will be compiled and compared 1 hour before and after each treatment and from daily pain ratings assessed at hospital admission until discharge. Hospital length of stay is recorded for each participant from date of randomization until date of discharge or date of death from any cause and compared to data extracted from the electronic health record system EPIC.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 19 years old or older
- Present with an uncomplicated sickle cell crisis at admission friom the emergency department
- < 19 years old
- pregnant female
- complicated sickle cell crisis present (i.e., concomitant MI, stroke, acute chest syndrome at time of presentation)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description treatment hyperbaric oxygen therapy this preliminary study will be a convenience sample of patients admitted to hospital for vaso-occlusive sickle cell crisis to be treated with hyperbaric oxygen in an effort to ameliorate pain and shorten the length of stay. In this sense, hyperbaric oxygen will be used as a treatment drug. Results will be compared with historical controls
- Primary Outcome Measures
Name Time Method Pain Assessment per Treatment one hour before and after each hyperbaric treatment Change in pain rating will be determined within one hour before and after each hyperbaric oxygen (HBO) treatment. The pain scale is 0-100, 0 being no pain and 100 being maximal pain imaginable for that participant. Pain assessments before and after each HBO treatment will be compiled and compared to determine treatment effectiveness.
- Secondary Outcome Measures
Name Time Method Hospital Length of Stay up to 1 month The hospital length of stay in days from date of randomization until date of discharge or date of death from any cause, whichever came first is recorded and compared to data extracted from the electronic health record system EPIC.
Pain Assessment for All Treatments up to 1 month (expected average of 3 days) Change in pain rating will be determined between enrollment and hospital discharge. The scale is 0-100, 0 being no pain and 100 being maximal pain imaginable for that participant. Pain assessments will occur at initial Emergency Department (ED) presentation and then every morning of admission until discharge. Pain completely resolved or max session number of 3 will be used as standard to halt HBO therapies.
Trial Locations
- Locations (1)
Unversity of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States