Satunnaistettu tutkimus, jossa verrattiin kolmea sumutettua fentanyyliannosta vanhemmilla aikuisilla
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Bangkok
-
Bangkok, Bangkok, Thaimaa, 10300
- Faculty of Medicine,Vajira Hospital
-
Bangkok, Bangkok, Thaimaa, 10300
- Jiraporn Sri-on
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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).
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: 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.
Muut nimet:
|
|
Active Comparator: 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.
Muut nimet:
|
|
Active Comparator: 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.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Efficacy in pain reduction following nebulized fentanyl administration at different dosages.
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Adverse events following nebulized fentanyl administration at different dosages.
Aikaikkuna: 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.
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Tutkijat
- Päätutkija: Supavit Punyapatipan, M.D., Faculty of medicine, Vajira hospital
- Päätutkija: Jiraporn Sri-on, M.D., Faculty of medicine, Vajira hospital
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
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Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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Avainsanat
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- 219/66 FB
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