Dantrolene for Lower Back Injury

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Lower Back InjuryDantrolene - Drug
Eligibility
18 - 80
All Sexes
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Study Summary

This trial will test whether a non-central nervous system muscle relaxant can help improve pain and sedation scores in patients undergoing lumbar fusion surgery.

Eligible Conditions
  • Lower Back Injury

Treatment Effectiveness

Study Objectives

0 Primary · 8 Secondary · Reporting Duration: Measured at 0, 1, 2, 3, 24, 48 hours after surgery

Duration of the patient's stay in the hospital, on average three days
Morphine Equivalent Dose
Hour 48
Numerical Rating Scale (NRS) for Pain
Hour 48
ICU Mobility Score
Richmond Agitation Sedation Scale (RASS)
Hour 48
Overall Benefit of Analgesia Score (OBAS)
Hour 24
ICU Length of Stay
Until discharge from the hospital, on average three days
Benzodiazepine use postoperatively
Hospital length of stay

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Dantrolene (Low Dose)
20%Hypotension
This histogram enumerates side effects from a completed 2009 Phase 1 & 2 trial (NCT00964548) in the Dantrolene (Low Dose) ARM group. Side effects include: Hypotension with 20%.

Trial Design

2 Treatment Groups

Dantrolene Group
1 of 2
Placebo Oral Tablet Group
1 of 2

Experimental Treatment

Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: Dantrolene · Has Placebo Group · Phase 2

Dantrolene Group
Drug
Experimental Group · 1 Intervention: Dantrolene · Intervention Types: Drug
Placebo Oral Tablet Group
Drug
PlaceboComparator Group · 1 Intervention: Placebo Oral Tablet · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dantrolene
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: measured at 0, 1, 2, 3, 24, 48 hours after surgery

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
777 Previous Clinical Trials
845,654 Total Patients Enrolled
Richard J Pollard, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center

Eligibility Criteria

Age 18 - 80 · All Participants · 3 Total Inclusion Criteria

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