Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00711698
Other study ID # NA_00001163
Secondary ID
Status Withdrawn
Phase Phase 2
First received July 7, 2008
Last updated March 22, 2017
Start date September 2007
Est. completion date September 1, 2009

Study information

Verified date March 2017
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research is being done to find out the best way to give narcotics for pain relief in adults with sickle cell disease and painful crisis. This study is a comparison of two ways of giving narcotics. The first way is what occurs now in the Emergency Acute Care Unit (EACU) where patients are given a single intravenous (iv) dose of a narcotic which is repeated by the nurse as needed to control the pain. The second way is to provide a single iv dose of narcotic and then allow the patient to push a button and receive one or more additional doses of narcotic when he/she thinks it is needed. Our hypothesis is that PCA will be a more effective way of controlling pain.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 1, 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- Documented sickle cell disease

- Signed consent in outpatient clinic or during a prior hospitalization

- 18+ years of age

- Seen in the ED with sickle cell pain crisis - this will be based on patients chief complaint that they are in a VOC.

- Requires IV administration of narcotics (has failed oral narcotic therapy at home)

- Must be 2 weeks since their last randomization on this study.

Exclusion Criteria:

- Contraindication to the use of IV narcotics

- Hypotension with systolic blood pressure (SBP) = 90

- Respiratory rate =9

- Altered mental status

- Patient unable to understand how to use the PCA device

- Patient unwilling to use PCA device

- Pulse oximeter reading of = 94% on room air

- Patient is allergic to IV morphine & hydromorphone & fentanyl.

- Patient is allergic to oral hydromorphone & morphine & oxycodone

- Patient has been randomized on this study 3 times before

Study Design


Intervention

Procedure:
Patient controlled analgesia
Patients in this arm will be treated with a bolus of narcotic followed by PCA
Drug:
nurse-administered intermittent IV bolus opioid therapy (NAIBOD)
In this arm patients will receive the current standard of care of IV bolus narcotic therapy

Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decrease in admissions for those treated with a PCA in the ED v those that are given bolus narcotic dosing Measured at time of discharge from ED
Secondary Length of stay Endpoints will be the time at which the decision for discharge from the EACU or transfer from the EACU to inpatient admission to the hospital is made
Secondary Total narcotic used Endpoints will be the time at which the decision for discharge from the EACU or transfer from the EACU to inpatient admission to the hospital is made
See also
  Status Clinical Trial Phase
Completed NCT02227472 - Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease
Recruiting NCT06301893 - Uganda Sickle Surveillance Study (US-3)
Recruiting NCT04398628 - ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Completed NCT02522104 - Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH) Phase 4
Recruiting NCT04688411 - An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease N/A
Terminated NCT03615924 - Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease Phase 3
Not yet recruiting NCT06300723 - Clinical Study of BRL-101 in Severe SCD N/A
Recruiting NCT03937817 - Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
Completed NCT04134299 - To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease N/A
Completed NCT04917783 - Health Literacy - Neurocognitive Screening in Pediatric SCD N/A
Completed NCT02580565 - Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide and Analgesics in the Sickle-cell Disease
Recruiting NCT04754711 - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition N/A
Completed NCT04388241 - Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD N/A
Recruiting NCT05431088 - A Phase 2/3 Study in Adult and Pediatric Participants With SCD Phase 2/Phase 3
Completed NCT01158794 - Genes Influencing Iron Overload State
Recruiting NCT03027258 - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome N/A
Withdrawn NCT02960503 - Macrolide Therapy to Improve Forced Expiratory Volume in 1 Second in Adults With Sickle Cell Disease Phase 1/Phase 2
Completed NCT02567695 - A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects Phase 1
Withdrawn NCT02630394 - A Pilot Study of Azithromycin Prophylaxis for Acute Chest Syndrome in Sickle Cell Disease Phase 1
Completed NCT02565082 - Evaluation of the Hemostatic Potential in Sickle Cell Disease Patients N/A