75 Participants Needed

Haloperidol for Back Pain

KM
JM
Overseen ByJessica McCoy, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Western Michigan University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ED) with a chief complaint of back pain. A total of 150 patients age 18-65 presenting to the emergency department with chief complaint of backpain will be enrolled from April 2024 - April 2025. Patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by telephone at 24 hours.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug Haloperidol for back pain?

Research suggests that Haloperidol can reduce the need for strong painkillers in various pain conditions and enhance the pain-relieving effects of opioids like morphine. It has been effective in reducing pain in conditions like severe radiation fibrosis and abdominal pain, indicating its potential to help with back pain as well.12345

How is the drug Haloperidol unique for treating back pain?

Haloperidol is unique for treating back pain because it is traditionally used as an antipsychotic medication to manage mental health conditions like schizophrenia, rather than pain management. This makes its use for back pain novel compared to other treatments that are specifically designed for pain relief.678910

Research Team

JM

Jessica McCoy, MD

Principal Investigator

Western Michigan University Homer Stryker M.D. School of Medicine

Eligibility Criteria

This trial is for adults aged 18-65 who come to the Bronson ED with acute, non-traumatic back pain and a pain score over 5 cm. It's not suitable for those outside this age range or with different types of back pain.

Inclusion Criteria

My pain level is more than 5 on a scale of 0 to 10.
I went to the ER because my back suddenly started hurting without any injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Participants receive either Haloperidol or Ketoralac and symptom levels are recorded at 30, 60, and 90 minutes

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment via telephone

24 hours
1 visit (telephone)

Treatment Details

Interventions

  • Haloperidol
Trial Overview The study tests Haloperidol against Ketorolac Tromethamine for managing acute musculoskeletal back pain in the ED. Patients are randomly assigned to either drug, and their symptoms are tracked at intervals up to 90 minutes, with a follow-up call after 24 hours.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: HaloperidolExperimental Treatment1 Intervention
Haloperidol 5 mg IM haloperidol
Group II: KetoralacActive Control1 Intervention
Ketoralac 30 mg IM

Haloperidol is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Haldol for:
  • Schizophrenia
  • Acute psychosis
  • Agitation
  • Delirium
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Approved in European Union as Haldol for:
  • Schizophrenia
  • Acute psychosis
  • Agitation
  • Delirium
  • Tourette's syndrome
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Approved in Canada as Haldol for:
  • Schizophrenia
  • Acute psychosis
  • Agitation
  • Delirium
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Approved in Japan as Haldol for:
  • Schizophrenia
  • Acute psychosis
  • Agitation
  • Delirium

Find a Clinic Near You

Who Is Running the Clinical Trial?

Western Michigan University School of Medicine

Lead Sponsor

Trials
6
Recruited
560+

Bronson Methodist Hospital

Collaborator

Trials
3
Recruited
3,600+

Findings from Research

Haloperidol has shown promise in significantly reducing or eliminating the need for narcotic analgesics in patients with intractable pain syndromes, based on previous reports of 10 patient cases.
The ongoing controlled double-blind study aims to evaluate Haloperidol's effectiveness as an adjunctive treatment for intractable cancer pain, exploring its potential analgesic properties and relationship to opiate receptors.
Analgesia and haloperidol: a hypothesis.Maltbie, AA., Cavenar, JO., Sullivan, JL., et al.[2022]
The combination of haloperidol and morphine significantly enhances pain relief in neuropathic pain without causing major side effects like constipation or motor incoordination, based on tests conducted over 10 days post-surgery.
Using haloperidol with morphine delays the development of morphine tolerance, allowing for more effective pain management over a longer period compared to morphine alone.
Haloperidol potentiates antinociceptive effects of morphine and disrupt opioid tolerance.Mena-ValdΓ©s, LC., Blanco-HernΓ‘ndez, Y., Espinosa-JuΓ‘rez, JV., et al.[2023]
Haloperidol was found to be an effective pain reliever for a patient suffering from severe radiation fibrosis and necrosis, both on its own and when used with opiates.
This case supports previous findings that haloperidol can enhance pain relief, suggesting the need for further clinical trials to explore its potential as an analgesic.
Haloperidol analgesia.Daw, JL., Cohen-Cole, SA.[2022]

References

Analgesia and haloperidol: a hypothesis. [2022]
Haloperidol potentiates antinociceptive effects of morphine and disrupt opioid tolerance. [2023]
Haloperidol analgesia. [2022]
Study of Haloperidol for Abdominal Pain in the Emergency Department (SHAPE). [2021]
5.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Effect of haloperidol on the analgesic activity of opiate agonists administered intracisternally and intrathecally]. [2013]
Comparison of Pregabalin Versus Placebo in Reduction of Pain due to Lumber Disc Herniation. [2020]
Efficacy and safety evaluation of once-daily OROS hydromorphone in patients with chronic low back pain: a pilot open-label study (DO-127). [2019]
DANTE Study: The First Randomized, Double-Blind, Placebo and Active-Controlled, Parallel Arm Group Study Evaluating the Analgesic Efficacy and Safety of Dexketoprofen TrometAmol aNd Tramadol Hydrochloride Oral FixEd Dose Combination on Moderate to Severe Acute Pain in Patients with Acute Low Back Pain-Rationale and Design. [2023]
Hydromorphone extended release for neuropathic and non-neuropathic/nociceptive chronic low back pain: a post hoc analysis of data from a randomized, multicenter, double-blind, placebo-controlled clinical trial. [2014]
Efficacy and safety of flupirtine modified release for the management of moderate to severe chronic low back pain: results of SUPREME, a prospective randomized, double-blind, placebo- and active-controlled parallel-group phase IV study. [2022]