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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06395428
• Other study ID #: WMed-2024-1032
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 31, 2024
• Est. completion date: April 15, 2027

Study information

• Verified date: April 2024
• Source: Western Michigan University School of Medicine
• Contact: Jessica McCoy, MD
• Phone: 269-337-6600
• Email: jessica.mccoy[@]wmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: April 15, 2027
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Emergencies

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Western Michigan University School of Medicine	Bronson Methodist Hospital

References & Publications (17)

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/ — View Citation

Cowling M, Covington S, Roehmer C, Musey P. Characterizing the role of haloperidol for analgesia in the Emergency Department. J Pain Manag. 2019;12(2):141-146. — View Citation

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 2 — View Citation

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. — View Citation

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.0b013e3283 — View Citation

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. — View Citation

Inayat F, Virk HU, Ullah W, Hussain Q. Is haloperidol the wonder drug for cannabinoid hyperemesis syndrome? BMJ Case Rep. 2017 Jan 4;2017:bcr2016218239. doi: 10.1136/bcr-2016-218239. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	Mean change in visual analog scale (VAS) of self-rated nausea severity	30, 60, and 90 minutes after drug administration
Secondary	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	24 hours
Secondary	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.	30, 60, and 90 minutes after drug administration
Secondary	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.	24 hours after enrollment up to 1 week

External Links

•   Haloperidol by Patriot Pharmaceuticals LLC / Johnson & Johnson Research & Development, LLC / Janssen Pharmaceutica NV / Janssen Pharmaceutica, NV HALOPERIDOL injection.