Haloperidol for Back Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Western Michigan University School of Medicine
Disqualifiers: Traumatic injury, Saddle anesthesia, Bowel dysfunction, others
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
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.
12345How 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.
678910Eligibility 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 am between 18 and 65 years old.
I went to the ER because my back suddenly started hurting without any injury.
Trial 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)
Participant Groups
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.
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:
🇺🇸 Approved in United States as Haldol for:
- Schizophrenia
- Acute psychosis
- Agitation
- Delirium
🇪🇺 Approved in European Union as Haldol for:
- Schizophrenia
- Acute psychosis
- Agitation
- Delirium
- Tourette's syndrome
🇨🇦 Approved in Canada as Haldol for:
- Schizophrenia
- Acute psychosis
- Agitation
- Delirium
🇯🇵 Approved in Japan as Haldol for:
- Schizophrenia
- Acute psychosis
- Agitation
- Delirium
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Bronson Methodist HospitalKalamazoo, MI
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Who Is Running the Clinical Trial?
Western Michigan University School of MedicineLead Sponsor
Bronson Methodist HospitalCollaborator
References
Analgesia and haloperidol: a hypothesis. [2022]We have previously reported 10 patient histories involving various intractable pain syndromes where the administration of Haloperidol either eliminated the need for narcotic analgesics or resulted in a significant reduction in narcotic dosage. We are presently undertaking a controlled double-blind evaluation of Haloperidol as an adjunctive treatment for intractable cancer pain. Based upon the reported clinical observations, these findings are discussed from the following aspects: 1. The isomeric similarity of Haloperidol to Meperidine. 2. Dose response between Haloperidol and analgesic effect. 3. The clinical literature regarding the use of Haloperidol for the effective withdrawal or maintenance of narcotic addicts. 4. The analgesic property as it relates to the opiate receptor.
Haloperidol potentiates antinociceptive effects of morphine and disrupt opioid tolerance. [2023]Haloperidol is an antipsychotic agent recently described as an antinociceptive drug able to mediate the antagonism of sigma-1 receptors while morphine is an opioid used in the treatment of neuropathic pain. The objectives of this work were to determine the type of interaction generated by the combination of morphine and haloperidol in neuropathic pain induced by chronic constriction injury and to evaluate morphine tolerance and side effects. The antiallodynic and anti-hyperalgesic effects of morphine (0.01-3.16 mg/kg, s.c.) and haloperidol (0.0178-0.1778 mg/kg, s.c.) were determined after single-doses, in monotherapy and combined, using the acetone and von Frey tests, respectively. Evaluations were performed until 10-days postsurgery. Data were processed using "Surface of Synergic Interaction analysis". The rotarod test was used to evaluate motor coordination, and the constipation test was performed using 5% charcoal. The effects of haloperidol and BD-1063, sigma-1 receptor antagonists, naloxone and PRE-084 (sigma-1 agonist) were determined using the morphine-tolerance model. Morphine (0.0316 mg/kg)+haloperidol (0.0178 mg/kg) was determined to be the optimal combination. Morphine-tolerance was observed on day 5 after 11 administrations, although in animals that received the combination, tolerance was delayed until day 8. PRE-084 and naloxone administered on day 5 in animals treated with the combination resulted in a blockade of its antiallodynic effects. Adverse effects of constipation or motor incoordination were not shown in animals treated with morphine + haloperidol. In conclusion, haloperidol enhances the antinociceptive effects of morphine without significant adverse effects, as it is able to disrupt or delay the morphine-tolerance in neuropathic pain.
Haloperidol analgesia. [2022]Haloperidol was observed to be an effective analgesic, alone and in combination with opiates, in a patient with severe radiation fibrosis and necrosis. Previously, high doses of methadone and morphine, along with amitriptyline, had caused dangerous sedative side effects without providing adequate pain relief. This case adds further support to the previous reports that haloperidol has significant analgesic or analgesic-potentiating properties. We suggest double-blind, controlled clinical trials and neurophysiologic studies to further clarify this exciting new role for haloperidol.
Study of Haloperidol for Abdominal Pain in the Emergency Department (SHAPE). [2021]Intravenous haloperidol has been shown to decrease milligram morphine equivalents (MME) of analgesia and reduce hospital admissions for diabetic gastroparesis. The objective of this study was to evaluate whether haloperidol decreases MME for the treatment of non-specific abdominal pain diagnoses in the emergency department (ED), including gastroparesis, cyclic vomiting, cannabinoid hyperemesis syndrome, and unspecified abdominal pain. The primary outcome compared the difference in MME between encounters. Secondary outcomes included admission rate, pain scores, length of stay, rescue therapy administration, and adverse effects.
[Effect of haloperidol on the analgesic activity of opiate agonists administered intracisternally and intrathecally]. [2013]The mu-agonist morphine more actively inhibited the complex reflex manifestations of pain responses (the Hafner test and hot plate) in mice as compared to the spinal pain reflexes (tail flick). The delta-agonist D-Ala2-D-Leu5-enkephalin (DADL) abolished the responses of both types in the same doses. Haloperidol potentiated the ability of morphine and DADL to inhibit nociceptive responses at the cerebral level. The potentiating effect of this neuroleptic on inhibition of spinal nociceptive responses by opiate agonists was only observed at a dose of 5 mg/kg. Haloperidol could also in some of the tests potentiate the antinociceptive effect of the kappa-agonist bremazocine and the sigma-agonist SKF 10.047, however their activity was significantly lower than that of morphine and DADL.
Comparison of Pregabalin Versus Placebo in Reduction of Pain due to Lumber Disc Herniation. [2020]Introduction Lower back pain is an extensive problem globally, and quite prevalent in Pakistan as well. In most cases of lower back pain, the cause is lumbar disc herniation. To treat this pain, there are various treatment options available. In this study, we aim to find the efficacy and safety of pregabalin in lower back pain due to lumbar disc herniation. Methods We conducted an open-label prospective trial in a public tertiary care hospital in Karachi, Pakistan, for a duration of five months, i.e. from July 2019 to December 2019. A total of 105 patients were randomized into two groups: pregabalin group and placebo group, and they were required to respond to visual analog scale (VAS) on day 0 and week 12 of the study. Results The results showed a significant reduction in pain over time in both the groups: pregabalin (p-value
Efficacy and safety evaluation of once-daily OROS hydromorphone in patients with chronic low back pain: a pilot open-label study (DO-127). [2019]To evaluate the safety, tolerability, and efficacy of once-daily osmotic controlled-release oral delivery system (OROS) hydromorphone in patients with chronic low back pain of moderate-to-severe intensity.
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]Despite a wide range of treatment approaches and the availability of treatment recommendations or guidelines, no consensus on the most effective pharmacological therapy of low back pain (LBP) has been reached yet. Therefore, additional clinical evidence, particularly if built upon a rigorous clinical trial design, an evidence-based medication choice, and broader inclusion criteria better acknowledging the heterogeneity and intrinsic variability of LBP is needed. The DANTE study has been designed to comprehensively assess the analgesic efficacy and tolerability of dexketoprofen/tramadol (DKP/TRAM) 75/25 mg in a large cohort of patients with moderate to severe acute LBP.
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]The aim of this study was to determine the efficacy and tolerability of hydromorphone extended release (ER) in patients with chronic low back pain (LBP) with or without a neuropathic component.
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]To demonstrate non-inferior/superior efficacy of flupirtine modified release (MR) compared with tramadol/placebo for the management of moderate to severe chronic low back pain (LBP).