N/A
N=73
Effect of Sedation on Diagnostic Injections
Sacroiliac Joint Pain · Sympathetically Maintained Pain
Bottom Line
View on ClinicalTrials.gov: NCT01472835 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Pain Score — 2.2; 3.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Midazolam (Drug); Fentanyl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score |
5.1; 5.6 | — |
| SECONDARY Pain Score |
5.1; 5.6 | — |
| SECONDARY Procedure-related Pain Score |
3.1; 5.5 | — |
| SECONDARY Oswestry Disability Index |
34.8; 40.6 | — |
| SECONDARY Satisfaction |
4.0; 3.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Chronic pain > 4 weeks but 3/10 in intensity
Exclusion Criteria
- No previous interventional pain-alleviating injections for the same condition within the past 3 years
- Uncontrolled coagulopathy
- Pregnancy, which will be ruled out by a urine pregnancy test in women of childbearing age
- Allergy to contrast dye or amide local anesthetics
- Unstable medical or psychiatric condition (e.g. unstable angina, congestive heart failure or severe depression) that could preclude an optimal treatment response
- Systemic infection
- Age 75 years
Data sourced from ClinicalTrials.gov (NCT01472835). 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.