En randomisert studie som sammenligner tre doser forstøvet fentanyl hos eldre voksne
A Randomized Study Comparing of Three Doses Nebulized Fentanyl in Older Adults With Severe Musculoskeletal Pain at the Emergency Department
This clinical trial compares three different nebulized fentanyl dosages for older persons experiencing severe musculoskeletal pain at the emergency department.
The main objective is:
Does the effectiveness of nebulized fentanyl at dosages of 2 mcg/kg, 3 mcg/kg, and 4 mcg/kg at 30 minutes differ in older patients who report to the emergency room with pain from musculoskeletal injuries?
Secondary outcome are:
- Incidence of adverse effects after drug administration at minutes 0, 15, 30, 45, 60, 75, 90, 105, 120
- Incidence of receiving other pain relief treatments (rescue therapy) in minutes 30, 45, 60, 75, 90, 105, 120 Participants will receive an explanation of the study and possible side effects, which may take approximately 5-10 minutes, without affecting the primary treatment of the patients. Consent will be obtained in this study, along with signing or fingerprinting as evidence in the consent form.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Participants will receive nebulized fentanyl for pain reduction at the pre-determined randomized dose, then researchers will follow up assessments of pain levels, vital signs, and any side effects at various intervals.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Bangkok
-
Bangkok, Bangkok, Thailand, 10300
- Faculty of Medicine,Vajira Hospital
-
Bangkok, Bangkok, Thailand, 10300
- Jiraporn Sri-on
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age more than or equal 65 years old.
- Presented with musculoskeletal pain within 3 days.
- Pain score on verbal numeric rating scale ≥ 5.
Exclusion Criteria:
- Patients need immediate intervention.
- Patients need acute rescue for acute coronary syndrome, respiratory failure, and stroke.
- Creatinine clearance < 30 ml/min, Cirrhosis stage III, IV (present with ascites and varices).
- Trauma >2 organ.
- Comorbidities of chronic obstructive pulmonary disease.
- Take MAO inhibitors within 14 days.
- History of opioid used within 8 hours.
- History of alcohol or drug abuse.
- History of fentanyl allergy.
- Patients with difficulty to communication (e.g. altered mental status, severe dementia (define by 6-items cognitive screening > 12, language barrier).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Nebulized fentanyl 2 mcg/kg
The researcher prepared fentanyl (the researcher informed the in-charge nurse to open the medicine cabinet and double-checked the dosage with the in-charge nurse). The dosage was 2 micrograms per kilogram of body weight (calculated based on the patient's actual weight in kilograms). The medication was contained in a nebulizer. It was then mixed with normal saline (0.9% normal saline) to a total volume of 5 milliliters and administered via nebulization. |
After the enrollment process, the main research assistant will take a brown envelope containing the randomization and hand it to the principal investigator in numerical order. The principal investigator will then open the envelope to determine the group assignment for the patient, revealing which fentanyl nebulization dosage group (2 mcg/kg, 3 mcg/kg and 4 mcg/kg) the patient will be placed in. In this study, participants will be divided into three groups as previously described. We evaluate pain score at 0, 15, 30, 45, 60, 75, 90, 105 and 120 minutes after receiving nebulized fentanyl by a train research assistance who is blind from the treatment dosage.
Andre navn:
|
|
Aktiv komparator: Nebulized fentanyl 3 mcg/kg
The researcher prepared fentanyl (the researcher informed the in-charge nurse to open the medicine cabinet and double-checked the dosage with the in-charge nurse). The dosage was 3 micrograms per kilogram of body weight (calculated based on the patient's actual weight in kilograms). The medication was contained in a nebulizer. It was then mixed with normal saline (0.9% normal saline) to a total volume of 5 milliliters and administered via nebulization. |
After the enrollment process, the main research assistant will take a brown envelope containing the randomization and hand it to the principal investigator in numerical order. The principal investigator will then open the envelope to determine the group assignment for the patient, revealing which fentanyl nebulization dosage group (2 mcg/kg, 3 mcg/kg and 4 mcg/kg) the patient will be placed in. In this study, participants will be divided into three groups as previously described. We evaluate pain score at 0, 15, 30, 45, 60, 75, 90, 105 and 120 minutes after receiving nebulized fentanyl by a train research assistance who is blind from the treatment dosage.
Andre navn:
|
|
Aktiv komparator: Nebulized fentanyl 4 mcg/kg
The researcher prepared fentanyl (the researcher informed the in-charge nurse to open the medicine cabinet and double-checked the dosage with the in-charge nurse). The dosage was 4 micrograms per kilogram of body weight (calculated based on the patient's actual weight in kilograms). The medication was contained in a nebulizer. It was then mixed with normal saline (0.9% normal saline) to a total volume of 5 milliliters and administered via nebulization. |
After the enrollment process, the main research assistant will take a brown envelope containing the randomization and hand it to the principal investigator in numerical order. The principal investigator will then open the envelope to determine the group assignment for the patient, revealing which fentanyl nebulization dosage group (2 mcg/kg, 3 mcg/kg and 4 mcg/kg) the patient will be placed in. In this study, participants will be divided into three groups as previously described. We evaluate pain score at 0, 15, 30, 45, 60, 75, 90, 105 and 120 minutes after receiving nebulized fentanyl by a train research assistance who is blind from the treatment dosage.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Efficacy in pain reduction following nebulized fentanyl administration at different dosages.
Tidsramme: 30 Minutes
|
Efficacy in pain reduction following nebulized fentanyl administration at dosages of 2 mcg/kg, 3 mcg/kg, and 4 mcg/kg in elderly patients presenting to the emergency department with musculoskeletal pain, using verbal numerical rating scale (VNRS) VNRS score ranges from 0 to 10, with a higher score indicating more severe pain. Ten indicates the worst pain, and zero indicates no pain. |
30 Minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse events following nebulized fentanyl administration at different dosages.
Tidsramme: 0, 15, 30, 45, 60, 75, 90, 105, 120 Minutes
|
Adverse events following nebulized fentanyl administration at dosages of 2 mcg/kg, 3 mcg/kg, and 4 mcg/kg in elderly patients presenting to the emergency department with with musculoskeletal pain |
0, 15, 30, 45, 60, 75, 90, 105, 120 Minutes
|
|
Events of rescue therapy following nebulized fentanyl administration at different dosages.
Tidsramme: 30, 45, 60, 75, 90, 105, 120 Minutes
|
Events of rescue therapy following nebulized fentanyl administration at dosages of 2 mcg/kg, 3 mcg/kg, and 4 mcg/kg in elderly patients presenting to the emergency department with musculoskeletal pain |
30, 45, 60, 75, 90, 105, 120 Minutes
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Supavit Punyapatipan, M.D., Faculty of medicine, Vajira hospital
- Hovedetterforsker: Jiraporn Sri-on, M.D., Faculty of medicine, Vajira hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
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- Herr KA, Garand L. Assessment and measurement of pain in older adults. Clin Geriatr Med. 2001 Aug;17(3):457-78, vi. doi: 10.1016/s0749-0690(05)70080-x.
- Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0.
- By the 2023 American Geriatrics Society Beers Criteria(R) Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria(R) for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023 Jul;71(7):2052-2081. doi: 10.1111/jgs.18372. Epub 2023 May 4.
- Chang HY, Daubresse M, Kruszewski SP, Alexander GC. Prevalence and treatment of pain in EDs in the United States, 2000 to 2010. Am J Emerg Med. 2014 May;32(5):421-31. doi: 10.1016/j.ajem.2014.01.015. Epub 2014 Jan 21.
- Chakour MC, Gibson SJ, Bradbeer M, Helme RD. The effect of age on A delta- and C-fibre thermal pain perception. Pain. 1996 Jan;64(1):143-152. doi: 10.1016/0304-3959(95)00102-6.
- Pergolizzi J, Boger RH, Budd K, Dahan A, Erdine S, Hans G, Kress HG, Langford R, Likar R, Raffa RB, Sacerdote P. Opioids and the management of chronic severe pain in the elderly: consensus statement of an International Expert Panel with focus on the six clinically most often used World Health Organization Step III opioids (buprenorphine, fentanyl, hydromorphone, methadone, morphine, oxycodone). Pain Pract. 2008 Jul-Aug;8(4):287-313. doi: 10.1111/j.1533-2500.2008.00204.x. Epub 2008 May 23.
- Teasell R, Dittmer DK. Complications of immobilization and bed rest. Part 2: Other complications. Can Fam Physician. 1993 Jun;39:1440-2, 1445-6.
- Tongbua S, Sri-On J, Thong-On K, Paksophis T. Non-inferiority of intranasal ketamine compared to intravenous morphine for musculoskeletal pain relief among older adults in an emergency department: a randomised controlled trial. Age Ageing. 2022 Mar 1;51(3):afac073. doi: 10.1093/ageing/afac073.
- Labroo RB, Paine MF, Thummel KE, Kharasch ED. Fentanyl metabolism by human hepatic and intestinal cytochrome P450 3A4: implications for interindividual variability in disposition, efficacy, and drug interactions. Drug Metab Dispos. 1997 Sep;25(9):1072-80.
- Grape S, Schug SA, Lauer S, Schug BS. Formulations of fentanyl for the management of pain. Drugs. 2010;70(1):57-72. doi: 10.2165/11531740-000000000-00000.
- Rosenblum A, Marsch LA, Joseph H, Portenoy RK. Opioids and the treatment of chronic pain: controversies, current status, and future directions. Exp Clin Psychopharmacol. 2008 Oct;16(5):405-16. doi: 10.1037/a0013628.
- Farahmand S, Shiralizadeh S, Talebian MT, Bagheri-Hariri S, Arbab M, Basirghafouri H, Saeedi M, Sedaghat M, Mirzababai H. Nebulized fentanyl vs intravenous morphine for ED patients with acute limb pain: a randomized clinical trial. Am J Emerg Med. 2014 Sep;32(9):1011-5. doi: 10.1016/j.ajem.2014.05.051. Epub 2014 Jun 12.
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- Puntillo F, Giglio M, Varrassi G. The Routes of Administration for Acute Postoperative Pain Medication. Pain Ther. 2021 Dec;10(2):909-925. doi: 10.1007/s40122-021-00286-5. Epub 2021 Jul 17.
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- Hess DR. Nebulizers: principles and performance. Respir Care. 2000 Jun;45(6):609-22.
- Bartfield JM, Flint RD, McErlean M, Broderick J. Nebulized fentanyl for relief of abdominal pain. Acad Emerg Med. 2003 Mar;10(3):215-8. doi: 10.1111/j.1553-2712.2003.tb01993.x.
- Miner JR, Kletti C, Herold M, Hubbard D, Biros MH. Randomized clinical trial of nebulized fentanyl citrate versus i.v. fentanyl citrate in children presenting to the emergency department with acute pain. Acad Emerg Med. 2007 Oct;14(10):895-8. doi: 10.1197/j.aem.2007.06.036.
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Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
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