Opioid Exposure for Respiratory Complications
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Pregnancy, Pulmonary pathology, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Fentanyl for respiratory complications?
Fentanyl is effective in managing breakthrough pain in cancer patients who are already on opioid therapy, as seen with the nasal spray formulation Lazanda. It is also used for conscious sedation during medical procedures, indicating its effectiveness in pain management and sedation.
12345Is fentanyl generally safe for human use?
Fentanyl, used in various forms like nasal sprays and patches, has been tested for safety in humans, especially for managing pain in cancer patients. It is important to note that fentanyl is a potent opioid, and its use requires careful management to ensure safety, including appropriate dosing and risk management protocols.
16789How does the drug Fentanyl Injection differ from other treatments for respiratory complications?
Fentanyl Injection is unique because it is a powerful opioid pain reliever that works by binding to specific receptors in the brain to reduce pain and can be administered intravenously, allowing for rapid onset of action. This is different from other treatments that may not provide such quick relief or may not be suitable for severe pain management.
1011121314Eligibility Criteria
This trial is for adult men and women who are having lower limb orthopedic surgery at St. Mary Hospital or Rochester Methodist within the Mayo Clinic in Rochester. It's not for those with lung conditions like COPD or asthma, anyone who doesn't want to participate in research, or pregnant individuals.Inclusion Criteria
I am an adult having leg surgery at St. Mary or Rochester Methodist Hospital.
Exclusion Criteria
I do not want to participate in research studies.
I have a lung condition like COPD or asthma that needs regular treatment.
Pregnant patients
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo ultrasound shear wave elastography examination while performing different breathing techniques after being administered varying doses of opioids during surgery
1 hour
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is looking into how different doses of an opioid called Fentanyl affect the diaphragm muscle's ability to work harder and generate force during breathing, especially after surgery.
3Treatment groups
Experimental Treatment
Group I: Ultrasound Shear Wave Elastography Examination - MidExperimental Treatment1 Intervention
Subjects identified as being administered mid dose opioids during an elective lower extremity orthopedic surgery per standard of care will undergo an ultrasound shear wave elastography examination while performing different breathing techniques.
Group II: Ultrasound Shear Wave Elastography Examination - LowerExperimental Treatment1 Intervention
Subjects identified as being administered low dose opioids during an elective lower extremity orthopedic surgery per standard of care will undergo an ultrasound shear wave elastography examination while performing different breathing techniques.
Group III: Ultrasound Shear Wave Elastography Examination - HigherExperimental Treatment1 Intervention
Subjects identified as being administered higher dose opioids during an elective lower extremity orthopedic surgery per standard of care will undergo an ultrasound shear wave elastography examination while performing different breathing techniques.
Fentanyl Injection is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Fentanyl for:
- Severe pain during and after surgery
- Breakthrough cancer pain
- Chronic pain management
🇪🇺 Approved in European Union as Fentanyl for:
- Severe pain during and after surgery
- Breakthrough cancer pain
- Chronic pain management
🇨🇦 Approved in Canada as Fentanyl for:
- Severe pain during and after surgery
- Breakthrough cancer pain
- Chronic pain management
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic MinnesotaRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Fentanyl nasal spray (Lazanda) for pain. [2013]The FDA has approved a nasal spray formulation of fentanyl (Lazanda-Archimedes) for management of breakthrough pain in adult cancer patients who are already receiving and are tolerant to opioid therapy. Fentanyl is already available in the US for intravenous, intrathecal, epidural, transdermal and oral transmucosal use.
"Macrodosing" Sublingual Buprenorphine and Extended-release Buprenorphine in a Hospital Setting: 2 Case Reports. [2023]To describe 2 case reports in which high-dose administration of sublingual buprenorphine/naloxone quickly stabilized fentanyl users who presented to the hospital. To discuss how early administration of extended-release buprenorphine, before the patient is discharged, may improve retention rates for outpatient buprenorphine treatment.
Drug utilization study on immediate release Fentanyl in Spain. Prevalence, incidence, and indication. [2021]We aimed to characterize the trends of immediate release fentanyl (IRF) use in Spain between 2012 and 2017 and indication for its use. IRF drugs are rapid-acting opioids approved to treat breakthrough cancer pain (BTCP) in patients already receiving maintenance opioid therapy for chronic cancer pain. A substantial increase in consumption of IRF has been observed with emerging cases of abuse and dependence, most of them in noncancer patients.
Fentanyl citrate (fentanyl sublimaze). [2013]Fentanyl (Sublimaze) is a synthetic opioid used as a combination drug for conscious sedation in patients requiring endoscopic diagnostic and therapeutic procedures. Fentanyl is generally used in place of meperidine (Demerol) in combination with droperidol (Inapsine) and midazolam (Versed), creating neuroleptanesthesia for patients undergoing procedures that require patient cooperation.
Quality of life and cancer pain: satisfaction and side effects with transdermal fentanyl versus oral morphine. [2022]To compare pain-related treatment satisfaction, patient-perceived side effects, functioning, and well-being in patients with advanced cancer who were receiving either transdermal fentanyl (Duragesic, Janssen Pharmaceuticals, Titusville, NJ) or sustained-release oral forms of morphine (MS Contin, Perdue Frederick Co, Norwalk, CT, or Oramorph SR, Roxanne Laboratories, Columbus, OH).
A Phase III study to assess the clinical utility of low-dose fentanyl transdermal system in patients with chronic nonmalignant pain. [2013]The transdermal fentanyl delivery system (fentanyl TTS; Duragesic) is currently widely available in patch strengths of 25, 50, 75, and 100 microg/h. However, a lower dose of 12 microg/h would allow optimal titration and fine tuning of the analgesic effect, and may be beneficial in certain patient populations such as the elderly or opioid-naïve. A 12 microg/h fentanyl TTS patch has been developed, and the clinical efficacy and safety tested in this single-arm, non-randomized, open-label, multicenter, 28-day trial in opioid-exposed and -naïve patients with moderate to severe pain for at least 6 months.
Nasal delivery of fentanyl. [2018]Fentanyl, a potent opioid analgesic, is rapidly and efficiently absorbed from the nasal cavity, giving significant potential for nasally administered fentanyl to be used in pain management. Many reported clinical studies have used nasally administered IV solution, often as drops, which requires high volumes of solution to deliver an effective dose, resulting in insignificant runoff and drip which, in turn, compromises absorption and efficacy. More recently, products have been developed and commercialised with features intended to overcome these drawbacks, notably delivering the dose as a spray in a lower volume of solution and, for one of the products, incorporating an in situ gelling agent with the aim of both reducing runoff/drip and modifying the fentanyl absorption profile. The commercial fentanyl nasal spray products (PecFent/Lazanda and Instanyl) are currently licensed solely for the treatment of breakthrough pain in cancer patients; they have a number of advantages over oral transmucosal (buccal/sublingual) products used in the same indication, including faster onset of action and easier administration, especially in patients suffering from oral cavity disorders associated with cancer treatment. Given the nature of fentanyl, regulatory agencies will expect that appropriate safety features are incorporated into the primary and secondary packaging in products intended for use by patients in the home and may also impose risk management protocols to control the distribution and prescription of controlled substances. These demands notwithstanding, intranasal fentanyl offers much future promise, including for additional indications and paediatric use.
Single-dose and multi-dose delivery systems for intranasal fentanyl spray are bioequivalent as demonstrated in a replicate pharmacokinetic study. [2013]Intranasal fentanyl spray (INFS, Instanyl®) was developed to treat cancer patients with Breakthrough Pain (BTP). INFS is delivered via a multi-dose delivery system (MDS) that is available in various dose strengths. The aim of this study was to demonstrate the pharmacokinetic bioequivalence of INFS single dose delivery system (SDS) in relation to the currently marketed MDS device.
Prophylactic Fentanyl Sublingual Spray for Episodic Exertional Dyspnea in Cancer Patients: A Pilot Double-Blind Randomized Controlled Trial. [2021]The optimal dose of fentanyl sublingual spray (FSS) for exertional dyspnea has not been determined.
Optimizing drug delivery to the lung: design of a CFC-free corticosteroid metered-dose aerosol system. [2019]The mandatory replacement of chlorofluorocarbons (CFCs) with ozone-friendly propellants, such as hydrofluoroalkanes (HFAs), has provided an opportunity to optimize aerosol design and improve drug delivery to pulmonary tissue. Asthma is an inflammatory disorder of the lungs that appears to affect both small and large airways, so ideally, inhaled corticosteroid should reach both central and peripheral sites. This review considers the development of an aerosol system containing beclomethasone dipropionate in hydrofluoroalkane-134a (HFA) propellant (Qvar, 3M Health Care, Loughborough, UK) designed to target medication delivery throughout the bronchopulmonary tree and to improve the therapeutic ratio (topical efficacy: systemic safety), thereby offering potential clinical benefits to asthma patients.
Pharmacokinetics of ciclesonide and desisobutyryl ciclesonide after administration via aqueous nasal spray or hydrofluoroalkane nasal aerosol compared with orally inhaled ciclesonide: an open-label, single-dose, three-period crossover study in healthy volunteers. [2019]Ciclesonide, an intranasal corticosteroid, is administered as a prodrug and is converted to the active metabolite, desisobutyryl ciclesonide, in the upper and lower airways. Previous studies have assessed systemic exposure with the ciclesonide hydrofluoroalkane metered dose inhaler (CIC HFA-MDI) and the ciclesonide aqueous nasal spray (CIC-AQ) formulations. However, systemic exposure with ciclesonide HFA nasal aerosol (CIC-HFA) developed for the treatment of allergic rhinitis has not been investigated.
Distribution of technetium-99m-labelled QVAR delivered using an Autohaler device in children. [2019]QVAR, an extrafine hydrofluoroalkane/beclomethasone dipropionate formulation, has been shown to double lung deposition in adults. The aim of the present study was to assess the total body deposition and distribution of technetium-99m-labelled (99mTc) QVAR in children after inhalation via an Autohaler. Sixteen male asthmatic children (5-14 yrs) inhaled labelled drug (
A Randomized Comparison of the Pharmacokinetics and Bioavailability of Fluticasone Propionate Delivered via Xhance Exhalation Delivery System Versus Flonase Nasal Spray and Flovent HFA Inhalational Aerosol. [2020]The exhalation delivery system with fluticasone propionate (Xhance®) has been shown to deliver drug substantially more broadly in the nasal cavity (particularly into superior/posterior regions), with less off-target loss of drug to drip-out and swallowing, than conventional nasal sprays. This open-label study evaluated the systemic bioavailability of Xhance® by comparing the pharmacokinetic (PK) properties of a single dose of fluticasone from 3 products administering the drug using 3 different devices: Xhance®, Flonase® (fluticasone propionate inhalational nasal spray), and Flovent® HFA (fluticasone propionate inhalational aerosol).
Placebo-controlled, comparative study of the efficacy and safety of triamcinolone acetonide inhalation aerosol with the non-CFC propellant HFA-134a in patients with asthma. Azmacort HFA Clinical Study Group. [2019]Triamcinolone acetonide (TAA) inhalation aerosol (Azmacort Inhalation Aerosol), a well-established corticosteroid treatment for bronchial asthma, utilizes the chlorofluorocarbon (CFC) propellant P-12, which will be phased out because of environmental concerns. Two TAA aerosol formulations have been developed using a non-chlorofluorocarbon propellant, HFA-134a (Azmacort HFA Inhalation Aerosol delivering TAA 75 microg/puff or 225 microg/puff).