Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants
25 de setembro de 2017 atualizado por: The Medicines Company
An Open Label Evaluation of the Safety and Clinical Utility of the Active, Separated System With Enhanced Controller (SSEC) Fentanyl 40 mcg for the Management of Acute Postoperative Pain in Pediatric Patients 12 to Less Than 18 Years of Age
The objective of this study is to evaluate the safety and clinical utility of the active, SSEC fentanyl 40 micrograms (mcg) for the management of acute, postoperative pain in pediatric participants.
Visão geral do estudo
Descrição detalhada
An open label evaluation of the safety and clinical utility of the active, SSEC fentanyl 40 mcg for the management of acute postoperative pain in pediatric participants 12 to less than 18 years of age.
Tipo de estudo
Intervencional
Inscrição (Real)
71
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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California
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Palo Alto, California, Estados Unidos, 94304
- Packard Children's Hospital at Stanford
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Florida
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Miami, Florida, Estados Unidos, 33136
- University of Miami/Jackson Memorial Hospital
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342
- Children's Healthcare of Atlanta
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Hospital, Charlotte R. Bloomberg Children's Center
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- St. Louis Children's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- The Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- Children's Hospital of Pittsburgh of UPMC
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Texas
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Dallas, Texas, Estados Unidos, 75235
- Children's Medical Center of Dallas
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Harborview Medical Center
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Children's Hospital of Wisconsin
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
12 anos a 17 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Participants whose parent(s) or guardian(s) have/has signed and dated an informed consent form for the participant to participate in the study, or participants who have provided written assent to participate in the study
- Male or female inpatients, age 12 to <18 years of age inclusive on the day of surgery
- Participants capable of understanding and cooperating with the requirements of the study, including being able to report their pain intensity using the 11-point Numeric Rating Scale and operate the SSEC
- American Society of Anesthesiologists physical status I, II or III
- Body weight of at least 40.0 kilogram (kg)
- Postoperative participants who have undergone general or regional anesthesia for abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery
- Postoperative participants who have been observed during recovery and are expected to remain hospitalized and have pain requiring parenteral opioids (that is, intravenous [IV] patient-controlled anesthesia) for the next 24 hours or longer
- Participants who are awake and breathing spontaneously with a respiratory rate of 14 to 18 breaths per minute, peripheral capillary oxygen saturation ≥93% (with or without supplemental oxygen), and able to answer questions and follow commands
- Participants who have been observed during recovery, who are awake, able to answer questions and follow commands, and who have been comfortable for at least 30 minutes, with a pain intensity score ≤4 (numeric rating scale 0-10), with or without titration to comfort with IV opioids
Exclusion Criteria:
- Participants who have undergone any surgery on the airway, head, or neck
- Participants who received an extended-release opioid within 48 hours prior to Hour 0 or who are expected to have postoperative analgesia supplied by a continuous regional technique or participant-controlled epidural analgesia
- Participants with a history of allergy or hypersensitivity to fentanyl, skin adhesives, and/or cetylpyridinium chloride
- Participants who are expected to require intensive care or will likely require additional surgical procedures within 36 hours
- Participants who received intra-operative and/or postoperative administration of opioids other than morphine, hydromorphone, fentanyl, sufentanil, or alfentanil. Exception: If there are no medical contraindications, meperidine (pethidine) up to 0.5 milligram/kg IV is permitted during recovery for shivering
- Participants who require airway support (nasal or oropharyngeal airway intubation, or laryngeal mask airway at the time of final baseline assessments (that is, at the time of IONSYS application [Hour 0])
- Participants who are known or suspected to be opioid tolerant, have a history of opioid dependence within 3 months before the start of the study, or who are known to have used illicit drugs or alcohol within 14 days of the start of the study
- Participants with active generalized skin disorders or active local skin disease that precludes SSEC application to the chest or upper arm
- Participants with any coexisting major medical conditions that are likely to interfere with study procedures including, but not limited to, psychiatric conditions, chronic depression, suicidal ideation, autism
- Positive pregnancy test for any female
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: SSEC Fentanyl
SSEC fentanyl iontophoretic transdermal system, 40 mcg fentanyl per activation.
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An opioid that has been administered parenterally as an anesthetic and analgesic for more than 20 years.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Assessment Of Participant's Ability To Use The SSEC
Prazo: Completed at the time of the participant's termination of study treatment (up to 72 hours after study drug administration)
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Investigator's assessment of participant's ability to use the SSEC system safely and effectively.
The assessment consisted of a 4-level categorical evaluation (poor, fair, good, and excellent).
Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.
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Completed at the time of the participant's termination of study treatment (up to 72 hours after study drug administration)
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Assessment Of Adherence Of The SSEC System To Skin
Prazo: Immediately prior to removal at each 24-hour time point, or at early withdrawal, for up to 3 consecutive days (up to 72 hours)
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The adhesion of each SSEC was evaluated immediately prior to removal at each 24-hour time point, or at early withdrawal.
Adhesion was recorded using the following classification: System adhered to at least 90% of the application area with no edges unattached; System adhered between 75% and 89%; System was <75% adhered and not taped; System was secured with tape.
The number of SSEC systems for all time points in each category is presented.
Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.
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Immediately prior to removal at each 24-hour time point, or at early withdrawal, for up to 3 consecutive days (up to 72 hours)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal
Prazo: Baseline, 1 hour and 24 hours after SSEC removal.
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Skin irritation at the SSEC application site was to be assessed immediately prior to placement of the study system and at 1 and 24 hours after removal of each study system.
The application site was to be scored using the following scale: 0=No evidence of irritation; 1=Minimal erythema, barely perceptible; 2=Definite erythema, readily visible, minimal edema, or minimal papular response; 3=Erythema and papules; 4=Definite edema; 5=Erythema, edema, and papules; 6=Vesicular eruption; 7=Strong reaction spreading beyond the application site.
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Baseline, 1 hour and 24 hours after SSEC removal.
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Number Of Participants To Experience Clinically Relevant Respiratory Depression (CRRD)
Prazo: From the time of application of the first system through 7 days following end of study drug administration.
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Respiratory function and occurrence of CRRD was defined as simultaneous occurrence of bradypnoea (respiratory rate <10 breaths per minute for participants 9-15 years of age and sustained for 1 minute, or <8 breaths per minute for participants 16-17 years of age), with excessive sedation (that is, the participant is not easily aroused).
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From the time of application of the first system through 7 days following end of study drug administration.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elliot J Krane, MD, Stanford Children's Health
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Hartrick CT, Bourne MH, Gargiulo K, Damaraju CV, Vallow S, Hewitt DJ. Fentanyl iontophoretic transdermal system for acute-pain management after orthopedic surgery: a comparative study with morphine intravenous patient-controlled analgesia. Reg Anesth Pain Med. 2006 Nov-Dec;31(6):546-54. doi: 10.1016/j.rapm.2006.08.011.
- Chelly JE, Grass J, Houseman TW, Minkowitz H, Pue A. The safety and efficacy of a fentanyl patient-controlled transdermal system for acute postoperative analgesia: a multicenter, placebo-controlled trial. Anesth Analg. 2004 Feb;98(2):427-433. doi: 10.1213/01.ANE.0000093314.13848.7E.
- Grond S, Hall J, Spacek A, Hoppenbrouwers M, Richarz U, Bonnet F. Iontophoretic transdermal system using fentanyl compared with patient-controlled intravenous analgesia using morphine for postoperative pain management. Br J Anaesth. 2007 Jun;98(6):806-15. doi: 10.1093/bja/aem102. Erratum In: Br J Anaesth. 2008 Jan;100(1):146.
- Minkowitz HS, Rathmell JP, Vallow S, Gargiulo K, Damaraju CV, Hewitt DJ. Efficacy and safety of the fentanyl iontophoretic transdermal system (ITS) and intravenous patient-controlled analgesia (IV PCA) with morphine for pain management following abdominal or pelvic surgery. Pain Med. 2007 Nov-Dec;8(8):657-68. doi: 10.1111/j.1526-4637.2006.00257.x.
- Minkowitz HS, Yarmush J, Donnell MT, Tonner PH, Damaraju CV, Skowronski RJ. Safety and tolerability of fentanyl iontophoretic transdermal system: findings from a pooled data analysis of four clinical trials. J Opioid Manag. 2010 May-Jun;6(3):203-10. doi: 10.5055/jom.2010.0018.
- Viscusi ER, Reynolds L, Chung F, Atkinson LE, Khanna S. Patient-controlled transdermal fentanyl hydrochloride vs intravenous morphine pump for postoperative pain: a randomized controlled trial. JAMA. 2004 Mar 17;291(11):1333-41. doi: 10.1001/jama.291.11.1333.
- Viscusi ER, Reynolds L, Tait S, Melson T, Atkinson LE. An iontophoretic fentanyl patient-activated analgesic delivery system for postoperative pain: a double-blind, placebo-controlled trial. Anesth Analg. 2006 Jan;102(1):188-94. doi: 10.1213/01.ane.0000183649.58483.77.
- Viscusi ER, Siccardi M, Damaraju CV, Hewitt DJ, Kershaw P. The safety and efficacy of fentanyl iontophoretic transdermal system compared with morphine intravenous patient-controlled analgesia for postoperative pain management: an analysis of pooled data from three randomized, active-controlled clinical studies. Anesth Analg. 2007 Nov;105(5):1428-36, table of contents. doi: 10.1213/01.ane.0000281913.28623.fd.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
29 de junho de 2015
Conclusão Primária (Real)
12 de setembro de 2016
Conclusão do estudo (Real)
12 de setembro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
10 de março de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de março de 2015
Primeira postagem (Estimativa)
23 de março de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
26 de outubro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de setembro de 2017
Última verificação
1 de setembro de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Complicações pós-operatórias
- Dor
- Manifestações Neurológicas
- Dor, Pós-operatório
- Efeitos Fisiológicos das Drogas
- Depressores do Sistema Nervoso Central
- Agentes do Sistema Nervoso Periférico
- Analgésicos
- Agentes do Sistema Sensorial
- Anestésicos Intravenosos
- Anestésicos Gerais
- Anestésicos
- Analgésicos, Opioides
- Narcóticos
- Adjuvantes, Anestesia
- Fentanil
Outros números de identificação do estudo
- PD2013-002
- 2014-002405-37 (Número EudraCT)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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