An interventional study of Midazolam and Fentanyl in Sacroiliac Joint Pain and Sympathetically Maintained Pain, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-12-15.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Diagnostic
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.
Sixty-eight patients with sacroiliac (SI) joint or sympathetically-maintained pain will be randomized in a crossover fashion to receive diagnostic nerve blocks either with or without intravenous sedation. Among those who obtain some benefit and return for a 2nd block, this 2nd procedure will be done with sedation if the first was done without sedation, and vice versa. Midazolam and fentanyl will be used for intravenous sedation, titrated to anxiolysis and analgesia. Pain scores (0-10 numerical rating scale, or NRS) and an activity log will be recorded over the 8-hours following the blocks via a pain diary. The first follow-up visit will be 4 weeks after the procedure. Patients who obtain some benefit but continue to report significant pain or who might otherwise benefit from a repeat procedure will have this second procedure performed with sedation if no sedation was given for the first procedure, and without sedation if sedation was administered for the first procedure. The post-procedure pain data will be recorded in the same fashion as the initial nerve block. The second follow-up visit will be 4 weeks after the 2nd block.
273 studies on the registry are indexed under Arthralgia; 41 are open to participants now.
This study's enrollment of 73 is above the median of 63 across 219 interventional studies indexed under Arthralgia.
Browse Arthralgia studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pt will receive sedation with their procedure
Drug: Midazolam · Drug: Fentanyl
Patient will not receive sedation during procedure
Used for anxiolysis
Used for analgesia and as a sedative
Pain Score
pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable
Time frame: through 6 hours after injection
Pain Score
0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain.
Time frame: 1-month
Procedure-related Pain Score
0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable
Time frame: 1 day
Oswestry Disability Index
Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability
Time frame: 1-month
Satisfaction
5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied.
Time frame: 1 day
| Milestone | Sedation | Control |
|---|---|---|
| Started | 37 | 36 |
| Completed | 35 | 36 |
| Not completed | 2 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable
| units on a scale | Sedation | Control |
|---|---|---|
| Pain Score | 2.2 ± 2.3 | 3.4 ± 2.8 |
0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain.
| units on a scale | Sedation | Control |
|---|---|---|
| Pain Score | 5.1 ± 2.9 | 5.6 ± 2.8 |
0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable
| units on a scale | Sedation | Control |
|---|---|---|
| Procedure-related Pain Score | 3.1 ± 2.8 | 5.5 ± 2.7 |
Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability
| units on a scale | Sedation | Control |
|---|---|---|
| Oswestry Disability Index | 34.8 ± 14.6 | 40.6 ± 17.9 |
5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied.
| units on a scale | Sedation | Control |
|---|---|---|
| Satisfaction | 4.0 ± 1.1 | 3.6 ± 1.4 |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sedation | — | 0/37 (0%) | 3/37 (8.1%) |
| Control | — | 0/36 (0%) | 6/36 (16.7%) |
| Event | Sedation | Control |
|---|---|---|
| Worse painMusculoskeletal and connective tissue disorders | 0/37 | 2/36 |
| NauseaGastrointestinal disorders | 1/37 | 1/36 |
| HeadacheNervous system disorders | 1/37 | 1/36 |
| WeaknessNervous system disorders | 0/37 | 1/36 |
| DizzinessGeneral disorders | 0/37 | 1/36 |
| dysphagiaGastrointestinal disorders | 1/37 | 0/36 |
| Age, Continuous(years) | Sedation | Control | Total |
|---|---|---|---|
| Mean | 49.7 ± 16.1 | 50.3 ± 13.8 | 50.0 ± 15.0 |
| Age, Categorical(Participants) | Sedation | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 32 | 35 | 67 |
| >=65 years | 5 | 1 | 6 |
| Gender(Participants) | Sedation | Control | Total |
|---|---|---|---|
| Female | 20 | 22 | 42 |
| Male | 17 | 14 | 31 |
| Region of Enrollment(participants) | Sedation | Control | Total |
|---|---|---|---|
| United States | 37 | 36 | 73 |
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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