drugset / Trial / NCT01472835
Effect of Sedation on Diagnostic Injections
Completed
73 enrolled
Johns Hopkins University
Walter Reed National Military Medical Center · collab
RandomizedCrossoverOpen-labelDiagnostic
Summary
Interventional pain procedures have diagnostic, prognostic and therapeutic value. It is well-documented that the reference standard for identifying a pain generator is a low-volume block performed with local anesthetic, with or without steroid. Many factors may increase the false positive (FP) rate of diagnostic and prognostic nerve blocks; however, the use of sedation is the most controversial and remediable. Proponents of sedation argue that it has little effect on the rate of positive diagnostic blocks, and may even reduce the false-negative rate. The purpose of this study is to determine the effect of intravenous sedation on pain relief and the "false-positive rate" after diagnostic nerve blocks.
Timeline
- Start
- 2011-03
- Primary completion
- 2013-02
- Completion
- 2013-02
Publications
- Background Cohen SP, Hurley RW. The ability of diagnostic spinal injections to predict surgical outcomes. Anesth Analg. 2007 Dec;105(6):1756-75, table of contents. doi: 10.1213/01.ane.0000287637.30163.a2.
- Cohen SP, Hameed H, Kurihara C, Pasquina PF, Patel AM, Babade M, Griffith SR, Erdek ME, Jamison DE, Hurley RW. The effect of sedation on the accuracy and treatment outcomes for diagnostic injections: a randomized, controlled, crossover study. Pain Med. 2014 Apr;15(4):588-602. doi: 10.1111/pme.12389. Epub 2014 Feb 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fentanyl | Other / unclassified | — | Intravenous |
| Subject | Midazolam | Small molecule | — | Intravenous |