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| Name | Class |
|---|---|
| Bronson Methodist Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haloperidol | Experimental | Haloperidol 5 mg IM haloperidol |
|
| Ketoralac | Active Comparator | Ketoralac 30 mg IM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haloperidol | Drug | Intramuscular injection of drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | Mean change in visual analog scale (VAS) of self-rated nausea severity | 30, 60, and 90 minutes after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Need for rescue medications |
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Inclusion Criteria:
Exclusion Criteria:
HR>120, SBP>180 or <90, temperature >38°, O2 saturation<92%
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica McCoy, MD | Contact | 269-337-6600 | jessica.mccoy@wmed.edu | |
| Katharine Mitchell, MA | Contact | 269-341-8364 | mitckath@bronsonhg.org |
| Name | Affiliation | Role |
|---|---|---|
| Jessica McCoy, MD | Western Michigan University Homer Stryker M.D. School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bronson Methodist Hospital | Recruiting | Kalamazoo | Michigan | 49007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12167140 | Background | 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. | |
| 32402480 | Background | 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. |
| Label | URL |
|---|---|
| Haloperidol by Patriot Pharmaceuticals LLC / Johnson \& Johnson Research \& Development, LLC / Janssen Pharmaceutica NV / Janssen Pharmaceutica, NV HALOPERIDOL injection. | View source |
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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.
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006220 | Haloperidol |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D007213 | Indomethacin |
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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.
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Treatment allocations will be revealed only after study completion, unless there is concern for a serious adverse event in which case treatment team and patient will be unblinded. Interim analysis will be performed at 34 participants to evaluate for effectiveness and power
| Ketorolac Tromethamine | Drug | Intramuscular injection of drug |
|
|
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 |
| 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 |
| 17306626 | Result | 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. |
| 28376873 | Result | 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. |
| 26802501 | Result | 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. |
| 25534654 | Result | 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. |
| 28797652 | Result | 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. |
| 33805916 | Result | 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. |
| 21119516 | Result | 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. |
| 29709398 | Result | 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. |
| 35636044 | Result | 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. |
| 19093703 | Result | 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. |
| 12629531 | Result | 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. |
| 11495717 | Result | 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. |
| 20226624 | Result | 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. |
| 28052951 | Result | 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. |
| 33193995 | Result | 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. |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |