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Back PainPhase 4NCT06395428

Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department

A Phase 4 study testing Haloperidol and Ketorolac Tromethamine in people with Back Pain and Chronic Pain, run by Western Michigan University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Back Pain, Chronic Pain
What is being tested?
Haloperidol and Ketorolac Tromethamine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
9 Jul 2024to 15 Apr 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 - 65 years old
  • Presenting to the Bronson ED with a chief complaint of acute, non-traumatic back pain
  • VAS score >5 cm

Who cannot join

  • Back pain due to traumatic injury
  • Experiencing saddle anesthesia
  • Has bowel or bladder dysfunction
  • Has an abnormal neurological exam
  • Requires imaging in ED
  • Has a Glascow coma score <15
Show all 15Show fewer
  • Has one or more abnormal vital signs:
  • HR>120, SBP>180 or <90, temperature >38°, O2 saturation<92%
  • Has an allergy to ketorolac or haloperidol
  • Has a known diagnosis of Lewy Body Dementia
  • Has a known diagnosis of glaucoma.
  • Is known to be pregnant or breastfeeding
  • Is a prisoner or ward of the state
  • Is unable to consent for themselves/ non-english speaking
  • In the opinion of the attending physician or investigator the patient should not participate in the research

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jessica McCoy, MD contact

269-337-6600

jessica.mccoy@wmed.edu

Katharine Mitchell, MA contact

269-341-8364

mitckath@bronsonhg.org

United States1 site, 1 recruiting

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

    Jessica McCoy, MD, 269-337-6600, jessica.mccoy@med.wmich.edu

    Katharine Mitchell, PhD, 269-341-8364, mitckath@bronsonhg.org

    Recruiting

Other trials in United States

About this study

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.

Being tested
Haloperidol, Ketorolac Tromethamine
Keywords
Haloperidol, Chronic Pain, Back Pain
Medical subject headings
Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HaloperidolDrug

    Also called Haldol

    Intramuscular injection of drug

  • Ketorolac TromethamineDrug

    Also called Toradol

    Intramuscular injection of drug

Study groups in NCT06395428
Study groupRoleWhat they receive
HaloperidolExperimentalHaloperidol 5 mg IM haloperidol
Receives: Drug: Haloperidol
KetoralacActive comparatorKetoralac 30 mg IM
Receives: Drug: Ketorolac Tromethamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale (VAS)

    Mean change in visual analog scale (VAS) of self-rated nausea severity

    Measured: 30, 60, and 90 minutes after drug administration

Secondary outcomes (3)

  1. Length of stay after enrollment

    Mean length of stay in minutes between the 2 groups will be assessed with a student's t test to assess for significant difference between groups

    Measured: 24 hours

  2. Need for rescue medications

    Need for rescue medications will be a Boolean variable recorded in redcaps that will be qualitatively assessed to compare the number of patients in each group requiring rescue medication.

    Measured: 30, 60, and 90 minutes after drug administration

  3. Patient Satisfaction

    This will be assessed based on the follow-up question "would you receive this treatment again?" on the follow-up phone call. Number of patients in each group that answer yes to this question will be qualitatively discussed in the results.

    Measured: 24 hours after enrollment up to 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2024
  2. Study start9 Jul 2024
  3. Primary completion15 Apr 2025 (estimated)
  4. Study completion15 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a single-center prospective randomized double-blinded non-inferiority trial with potential assessment of superiority comparing haloperidol to ketorolac for the treatment of back pain.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06395428
Sponsor's protocol ID
WMed-2024-1032
Status last verified
Jul 2024
First submitted
1 Feb 2024
Last updated
10 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: The subject's info collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Publications

  • Silberstein SD, Peres MF, Hopkins MM, Shechter AL, Young WB, Rozen TD. Olanzapine in the treatment of refractory migraine and chronic daily headache. Headache. 2002 Jun;42(6):515-8. doi: 10.1046/j.1526-4610.2002.02126.x.

    PubMed 12167140

  • McCoy JJ, Aldy K, Arnall E, Petersen J. Treatment of Headache in the Emergency Department: Haloperidol in the Acute Setting (THE-HA Study): A Randomized Clinical Trial. J Emerg Med. 2020 Jul;59(1):12-20. doi: 10.1016/j.jemermed.2020.04.018. Epub 2020 May 10.

    PubMed 32402480

  • Todd KH, Ducharme J, Choiniere M, Crandall CS, Fosnocht DE, Homel P, Tanabe P; PEMI Study Group. Pain in the emergency department: results of the pain and emergency medicine initiative (PEMI) multicenter study. J Pain. 2007 Jun;8(6):460-6. doi: 10.1016/j.jpain.2006.12.005. Epub 2007 Feb 15.

    PubMed 17306626

  • Edwards J, Hayden J, Asbridge M, Gregoire B, Magee K. Prevalence of low back pain in emergency settings: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Apr 4;18(1):143. doi: 10.1186/s12891-017-1511-7.

    PubMed 28376873

  • Kea B, Fu R, Lowe RA, Sun BC. Interpreting the National Hospital Ambulatory Medical Care Survey: United States Emergency Department Opioid Prescribing, 2006-2010. Acad Emerg Med. 2016 Feb;23(2):159-65. doi: 10.1111/acem.12862. Epub 2016 Jan 23.

    PubMed 26802501

  • Hoppe JA, Kim H, Heard K. Association of emergency department opioid initiation with recurrent opioid use. Ann Emerg Med. 2015 May;65(5):493-499.e4. doi: 10.1016/j.annemergmed.2014.11.015. Epub 2014 Dec 18.

    PubMed 25534654

  • Ruhm CJ. Geographic Variation in Opioid and Heroin Involved Drug Poisoning Mortality Rates. Am J Prev Med. 2017 Dec;53(6):745-753. doi: 10.1016/j.amepre.2017.06.009. Epub 2017 Aug 7.

    PubMed 28797652

  • Bertrand S, Meynet G, Taffe P, Della Santa V, Fishman D, Fournier Y, Frochaux V, Ribordy V, Rutschmann OT, Hugli O. Opiophobia in Emergency Department Healthcare Providers: A Survey in Western Switzerland. J Clin Med. 2021 Mar 25;10(7):1353. doi: 10.3390/jcm10071353.

    PubMed 33805916

  • Gueant S, Taleb A, Borel-Kuhner J, Cauterman M, Raphael M, Nathan G, Ricard-Hibon A. Quality of pain management in the emergency department: results of a multicentre prospective study. Eur J Anaesthesiol. 2011 Feb;28(2):97-105. doi: 10.1097/EJA.0b013e3283418fb0.

    PubMed 21119516

  • Duncan RW, Smith KL, Maguire M, Stader DE 3rd. Alternatives to opioids for pain management in the emergency department decreases opioid usage and maintains patient satisfaction. Am J Emerg Med. 2019 Jan;37(1):38-44. doi: 10.1016/j.ajem.2018.04.043. Epub 2018 Apr 22.

    PubMed 29709398

  • Rech MA, Griggs C, Lovett S, Motov S. Acute pain management in the Emergency Department: Use of multimodal and non-opioid analgesic treatment strategies. Am J Emerg Med. 2022 Aug;58:57-65. doi: 10.1016/j.ajem.2022.05.022. Epub 2022 May 22.

    PubMed 35636044

  • Verdu B, Decosterd I, Buclin T, Stiefel F, Berney A. Antidepressants for the treatment of chronic pain. Drugs. 2008;68(18):2611-32. doi: 10.2165/0003495-200868180-00007.

    PubMed 19093703

  • Kroeze WK, Hufeisen SJ, Popadak BA, Renock SM, Steinberg S, Ernsberger P, Jayathilake K, Meltzer HY, Roth BL. H1-histamine receptor affinity predicts short-term weight gain for typical and atypical antipsychotic drugs. Neuropsychopharmacology. 2003 Mar;28(3):519-26. doi: 10.1038/sj.npp.1300027.

    PubMed 12629531

  • Kiser RS, Cohen HM, Freedenfeld RN, Jewell C, Fuchs PN. Olanzapine for the treatment of fibromyalgia symptoms. J Pain Symptom Manage. 2001 Aug;22(2):704-8. doi: 10.1016/s0885-3924(01)00302-5.

    PubMed 11495717

  • Seidel S, Aigner M, Ossege M, Pernicka E, Wildner B, Sycha T. Antipsychotics for acute and chronic pain in adults. J Pain Symptom Manage. 2010 Apr;39(4):768-78. doi: 10.1016/j.jpainsymman.2009.09.008. Epub 2010 Mar 11.

    PubMed 20226624

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Haloperidol and Ketorolac Tromethamine in people with Back Pain and Chronic Pain, run by Western Michigan University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jessica McCoy, MD (269-337-6600, jessica.mccoy@wmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: 30, 60, and 90 minutes after drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06395428, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.

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