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Recruiting NCT06395428

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

Phase IV Interventional Back Pain Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Haloperidol, Ketorolac Tromethamine.
Who it may be relevant to
Registry conditions: Back Pain, Chronic Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Haloperidol
    Intramuscular injection of drug
  • Drug Ketorolac Tromethamine
    Intramuscular injection of drug

Primary outcome measures

  • Visual Analog Scale (VAS) [Time frame: 30, 60, and 90 minutes after drug administration]
Secondary outcome measures (3)
  • Length of stay after enrollment [Time frame: 24 hours]
  • Need for rescue medications [Time frame: 30, 60, and 90 minutes after drug administration]
  • Patient Satisfaction [Time frame: 24 hours after enrollment up to 1 week]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Bronson Methodist Hospital — Kalamazoo

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 33805916

Identifiers

NCT: NCT06395428 · WMed-2024-1032

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗