Treatment Side EffectsPhase 3NCT06689124
A Randomized Study Comparing of Three Doses Nebulized Fentanyl in Older Adults
A Phase 3 study testing Nebulized fentanyl in people with Treatment Side Effects and Musculoskeletal Pain, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 2 sites in Thailand.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Treatment Side Effects, Musculoskeletal Pain
- What is being tested?
- Nebulized fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Jul 2024to 1 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age more than or equal 65 years old.
- Presented with musculoskeletal pain within 3 days.
- Pain score on verbal numeric rating scale ≥ 5.
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Faculty of Medicine,Vajira Hospital
Bangkok, Bangkok, 10300
Jiraporn Sri-on
Bangkok, Bangkok, 10300
About this study
Official title: 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:
Read more
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.
Read the detailed description
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.
- Conditions
- Treatment Side Effects, Musculoskeletal Pain
- Being tested
- Nebulized fentanyl
- Keywords
- fentanyl, opioid, nebulized, musculoskeletal pain, elderly, emergency room, randomized controlled trial, Thai
- Medical subject headings
- Musculoskeletal Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized fentanylDrug
Also called Nebulized fentanyl dosage
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.
| Study group | Role | What they receive |
|---|---|---|
| Nebulized fentanyl 2 mcg/kg | Active comparator | 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. Receives: Drug: Nebulized fentanyl |
| Nebulized fentanyl 3 mcg/kg | Active comparator | 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. Receives: Drug: Nebulized fentanyl |
| Nebulized fentanyl 4 mcg/kg | Active comparator | 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. Receives: Drug: Nebulized fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in pain reduction following nebulized fentanyl administration at different dosages.
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.
Measured: 30 Minutes
Secondary outcomes (2)
Adverse events following nebulized fentanyl administration at different dosages.
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
Measured: 0, 15, 30, 45, 60, 75, 90, 105, 120 Minutes
Events of rescue therapy following nebulized fentanyl administration at different dosages.
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
Measured: 30, 45, 60, 75, 90, 105, 120 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Jul 2024
- Primary completion1 Jul 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Treatment Side EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Sponsor type
- Other government
- Collaborators
- Navamindradhiraj University
- Responsible party
- Principal investigator, Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Investigators
- Supavit Punyapatipan, M.D., Principal investigator, Faculty of medicine, Vajira hospitalJiraporn Sri-on, M.D., Principal investigator, Faculty of medicine, Vajira hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689124
- Sponsor's protocol ID
- 219/66 FB
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24560834Chakour 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.
PubMed 8867257Herr 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.
PubMed 11459715Pergolizzi 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.
PubMed 18503626Vlaeyen 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.
PubMed 10781906Teasell R, Dittmer DK. Complications of immobilization and bed rest. Part 2: Other complications. Can Fam Physician. 1993 Jun;39:1440-2, 1445-6.
PubMed 8324412Tongbua 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.
PubMed 35348606Labroo 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.
PubMed 9311623By 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.
PubMed 37139824Grape 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.
PubMed 20030425Rosenblum 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.
PubMed 18837637Farahmand 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.
PubMed 25027194Sabri A, Szalas J, Holmes KS, Labib L, Mussivand T. Failed attempts and improvement strategies in peripheral intravenous catheterization. Biomed Mater Eng. 2013;23(1-2):93-108. doi: 10.3233/BME-120735.
PubMed 23442240Yalcinli S, Akarca FK, Can O, Sener A, Akbinar C. Factors affecting the first-attempt success rate of intravenous cannulation in older people. J Clin Nurs. 2019 Jun;28(11-12):2206-2213. doi: 10.1111/jocn.14816. Epub 2019 Mar 13.
PubMed 30786094Puntillo 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.
PubMed 34273095
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing of Three Doses Nebulized Fentanyl in Older Adults With Severe Musculoskeletal Pain at the Emergency Department
- ClinicalTrials.gov ID
- NCT06689124
- Acronym / sponsor ID
- 219/66 FB
- Conditions
- Treatment Side Effects, Musculoskeletal Pain
- Keywords
- fentanyl, opioid, nebulized, musculoskeletal pain, elderly, emergency room, randomized controlled trial, Thai
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira HospitalOther government
- Collaborators
- Navamindradhiraj University
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nebulized fentanyl 2 mcg/kg | Active comparator | Drug: Nebulized fentanylThe 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. |
| Nebulized fentanyl 3 mcg/kg | Active comparator | Drug: Nebulized fentanylThe 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. |
| Nebulized fentanyl 4 mcg/kg | Active comparator | Drug: Nebulized fentanylThe 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. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age more than or equal 65 years old.
- Presented with musculoskeletal pain within 3 days.
- Pain score on verbal numeric rating scale ≥ 5.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulized fentanylAlso: Nebulized fentanyl dosageAfter 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. | Drug | Nebulized fentanyl 2 mcg/kg, Nebulized fentanyl 3 mcg/kg, Nebulized fentanyl 4 mcg/kg |
Primary outcome
Efficacy in pain reduction following nebulized fentanyl administration at different dosages.
Time frame: 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.
2 secondary outcomes
Adverse events following nebulized fentanyl administration at different dosages.
Time frame: 0, 15, 30, 45, 60, 75, 90, 105, 120 Minutes
Events of rescue therapy following nebulized fentanyl administration at different dosages.
Time frame: 30, 45, 60, 75, 90, 105, 120 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Results publication: PubMed 24560834Chang 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.
- Results publication: PubMed 8867257Chakour 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.
- Results publication: PubMed 11459715Herr 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.
- Results publication: PubMed 18503626Pergolizzi 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.
- Results publication: PubMed 10781906Vlaeyen 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.
- Results publication: PubMed 8324412Teasell R, Dittmer DK. Complications of immobilization and bed rest. Part 2: Other complications. Can Fam Physician. 1993 Jun;39:1440-2, 1445-6.
- Results publication: PubMed 35348606Tongbua 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.
- Results publication: PubMed 9311623Labroo 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.
- Results publication: PubMed 37139824By 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.
- Results publication: PubMed 20030425Grape 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.
- Results publication: PubMed 18837637Rosenblum 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.
- Results publication: PubMed 25027194Farahmand 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.
- 32\. Ding D, Ishag S. Aldrete Scoring System \[Internet\]. StatPearls; 2023 \[cited 2023 Nov 25\].Link provided by the sponsor.
- 13\. Norman G. Bowery, Fentanyl, Editor(s): S.J. Enna, David B. Bylund, xPharm: The Comprehensive Pharmacology Reference, Elsevier, 2007, Pages 1-5, ISBN 9780080552323Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Supavit Punyapatipan, M.D. principal investigator
Faculty of medicine, Vajira hospital
Jiraporn Sri-on, M.D. principal investigator
Faculty of medicine, Vajira hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nebulized fentanyl in people with Treatment Side Effects and Musculoskeletal Pain, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in pain reduction following nebulized fentanyl administration at different dosages. (time frame: 30 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06689124, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.