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    IRB Protocol.doc.doc IRB Protocol.doc.doc Document Transcript

    • CPHS Protocol Multicenter Prospective Analysis of Pediatric Sedation Practice – The Pediatric Sedation Research Consortium Principal Investigator: Joseph P. Cravero MD Primary Contacts: George T. Blike MD Purpose: We wish to understand the manner in which pediatric sedation is delivered at various institutions throughout the United States, Canada, Europe, and Israel. This study will allow understanding of the drugs used for pediatric sedation, the efficacy of the sedation methods, the efficiency of pediatric sedation service, and the incidence of critical events in pediatric sedation as delivered in a wide variety of venues. Hypothesis: Pediatric sedation services vary greatly in the manner they are delivered throughout North America and overseas. The efficacy, efficiency, and safety associated with the delivery of pediatric sedation will be variable and relate directly to the manner in which sedation is delivered. Introduction: Every year millions of children around the world are given sedation for diagnostic and therapeutic procedures. These procedures are performed both in the hospital setting and in physician and dental offices around the country. The personnel that provide the sedation vary from briefly trained nursing personnel to experienced pediatric anesthesiologists. The sedative drugs used, techniques employed, and safety standards vary greatly from one location to another, and even within any given institution. The care provided depends on the individuals providing sedation, the time of day the sedation is being delivered, and the area within the hospital where the sedation is being given. In essence, practitioners who are attempting to achieve the same result – that of a calm, generally still child for a procedure – use widely varying techniques and medications to produce these conditions. Few areas of medical practice remain as non-standardized as pediatric sedation practice. Hospitals and dental practices struggle with the logistical concerns of how to provide adequate service for all pediatric patients who require sedation/anesthesia. Requests for high quality sedation services have increased as the public becomes more aware of new pain management techniques for children. Unfortunately, sedation services are required in widely varying locations within an institution. In addition, pediatric sedation may be required at any time of the day or night. Expert sedation providers are simply not available to provide this service given these requirements and case load. The result of this mismatch of supply and demand for sedation service has been a myriad of different sedation protocols and drug combinations in various hospitals and offices (even departments). Possibly most concerning has been the lack of communication between various specialties that provide sedation for children. For example, pediatric emergency medicine physicians do not always involve pediatric anesthesiologists when developing protocols for sedation in the emergency department. Similarly, research in pediatric sedation produced by dentists is almost never read or appreciated by radiologists trying to accomplish the same result. Our challenge with this study is to search beyond the preconceived notions, “turf battles”, and ignorance that exists between various specialists in order to explore the current state of this art in medicine. To date there has been no large, multicenter, studies to explore the details of pediatric sedation practice. Sedation studies available in the literature have reported the results sedations involving several hundred patients – most often in a retrospective manner. This study will allow prospective data from a number of large institutions to be shared in order to produce data with the power required to make true estimates of the efficacy, efficiency, and safety of pediatric sedation practice. Our study will collect information on the patients, procedures, and medications involved in pediatric sedation at the member institutions over a one year period. Outcomes followed will include (but not be limited to): 1) the success/failure in producing sedation for a given child 2) the time required to induce sedation 3) the quality of the sedation produced 4) the time required to awaken from sedation 5) any adverse events associated with the sedation. 5) the effects of comorbid conditions on the delivery of sedatioin.
    • Data from this study will be invaluable in developing new paradigms for pediatric sedation delivery and guide efforts for improvement in the delivery of patient care in this field for years to come. Previous work on this subject: Previous studies on pediatric sedation have documented multiple attempts to accommodate the need for pediatric sedation. Some services require direct physician involvement while others rely on trained nursing personnel. Still others have developed the concept of a “sedation room” or a “sedation team.” (1) The reported efficacy of these different strategies is mixed. The major goals of pediatric procedural sedation are to provide anxiety relief, pain control, and (usually) a still child. The rate of failure to achieve these goals has been reported by various investigators to be as low as 2-3% (2,3,4) and by others to be 10-20%. (5-9) When sedation fails, procedures are procedures are performed on children who are crying, struggling and requiring significant restraint. Theroux et al. described the common practice of suturing children who have lacerations without sedation using local anesthesia and papoose boards (9). As expected, adding sedation dramatically reduced crying and struggling and increased parental satisfaction. Similarly, inadequate preoperative sedation has clearly been linked to stress in children and their families surrounding surgical procedures (10). Aside from psychological trauma, diagnostic procedure quality has been documented to suffer when movement is not controlled, often requiring a procedure to be rescheduled with an anesthesiology team providing the sedation. Multiple centers, report an ~15% cancellation rate for radiological procedures (MRIs, CT scans, etc.) in children due to excessive movement (5-7). The safety of pediatric sedation is also problematic. Sedation safety relates to how often a sedative drug produces an unwanted side effect, or toxicity. The most serious complication of pediatric procedural sedation, death, is secondary to the respiratory depressant side effect of sedative medications. The incidence of death during pediatric sedation is low but it is associated with a prevalent situation (millions of children receive sedation annually) (11). A study by Coté et. al. evaluated almost one hundred incidents of death or permanent neurological injury associated with pediatric sedation over a 10 year period. (12). His analysis reveals that the overwhelming majority of these deaths was preventable and due to operator error—thus labeled “sedation errors”. Most of the deaths could be related to the known respiratory depressant side effects of the sedative medication used. Expert consensus that respiratory depression caused by sedative drugs should not lead to death catalyzed the American Academy of Pediatrics (AAP), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and the American Society of Anesthesiology to issue practice guidelines for sedation. (13-15) Unfortunately, even clinicians adhering to current practice guidelines for pediatric procedural sedation appear to be at risk of causing iatrogenic injuries. One center implemented the AAP guidelines for pediatric sedation, and then prospectively followed 1140 children (age 2.96 + - 3.7 years) sedated for procedures by non-anesthesiologists using a quality assurance tool. Approximately 13% of the children received inadequate sedation. They also reported a 5.3% incidence of respiratory events including one in which a child stopped breathing (5). Despite the need, pediatric procedural sedation has undergone precious little organized or scientific analysis. There are no large multi-institutional studies available to allow some estimation of the effectiveness or safety of a given drug or technique on a large scale. Such information would fill a much needed information void and help direct the future development of practice parameters and future investigation into sedation drugs and techniques. Why this study is important to sedation providers?: We feel it is important to determine if the incidence the overall safety, efficacy, and efficiency of pediatric sedation as it is provided in various sites across North America and in Europe. Data from the study will lead to evaluation of practice and the development of better practice protocols for pediatric sedation. Why this study is different than previous investigations?: As stated above, there is currently no large multicenter studies that would allow a large scale evaluation of how pediatric sedation is provided and how well various sedation medications and techniques work. Materials and Method: Study Type: Prospective survey of pediatric sedation practice involving collection of data from (approximately) approximately 22 member institutions over the period of one year.
    • Method: Sedation will be provided as per routine practice at all participating institutions. At the time of sedation a data sheet will be completed that includes the following: 1) Patient number (for the institution) 2) Patient age 3) Patient weight 4) Sex 5) Coexisting medical problems or issues 6) Procedure to be performed 7) Medication(s) used and route of delivery 8) Monitoring present during the procedure 9) Type of provider delivering sedation (RN, MD etc – and specialty training as appropriate 10) Sedation achieved successfully for the procedure – yes or no 11) Time required from starting sedation med to induction of sedation. 12) Child calm and still for procedure or were the conditions adequate? (yes or no) 13) Time from end of the procedure to discharge (mins) 14) Side effects of sedation (nausea, vomiting, delirium) 15) Adverse events (oxygen desaturation, apnea, need for hospitalization, death) 16) NPO status at the time of the sedation/procedure. Data will be reported to the central collection server in a confidential manner over a web-based collection tool. The storage of this data will occur at Dartmouth College at the Clinical Trials Center. No information that would directly identify the patient will be transmitted. Each institution will be responsible for any “tracking” of the patient information back to the patient chart – and this must be in keeping with local institutional rules. Each institution will have a unique identifier and each patient will be numbered from each institution. Each institution will have ready access to their own data at any time through the Clinical Trials Center. In addition, a quarterly report will be generated that will give a collated analysis of the data submitted from each institution and comparison will be made to data submitted from the consortium group as a whole. Outcome Data: Outcome data will be taken from that submitted (list above). 1. The success/failure rate for sedation will be considered with respect to procedure, age, sex, and drugs (techniques) used. 2. The incidence of adverse reactions will be computed in consideration of the total number of cases performed. This incidence will be evaluated in relation to age, sex, procedure, NPO status, and drugs/techniques used. 3. Comparison will be made in terms of the drugs/techniques used for the same procedures at different institutions. 4. Conditions reported during procedures will be compared between centers and in consideration of age, sex, procedure, and drugs/techniques used. 5. Monitors present during procedures will be compared. 6. The training of the providers involved in the sedation activity will be compared across institutions – and cross correlation with success rates, conditions, and any adverse outcomes will be made. 7. Time to achieve sedation and to discharge from the hospital will be compared between providers and institutions with consideration of age, sex, procedure, and drugs/techniques used. Location of the Study: The study will take place at all locations where pediatric sedation is delivered in Dartmouth Hitchcock Medical Center. Data from our institution will be compared to all other institutions participating in the Pediatric Sedation Research Consortium (see appendix A) Timetable: The time required to complete the study should be approximately 1year.
    • Selection Criteria: All patients undergoing sedation or specific distraction intervention with the intent of accomplishing a procedure will have their data entered into the consortium database via a web based module. Exclusion Criteria: N/A Recruitment: Patients and guardians will be informed that a study protocol exists via brochures describing the project. A general description of the study will be given. Competency: N/A Informed Consent: REQUEST FOR WAIVER OF CONSENT : A. This project involves the collection of a limited data set of information on a large group of patients. There will be no change in care delivered and there will be no transmission of patient-identifiable information. B. Alteration or waiver will not adversely affect privacy rights and welfare of individuals This is a limited data set. Patient identity is protected for all involved. C. Research could not practicably be conducted without the alteration or waiver; In order to have a valid data set, we need to have as close to 100% data collection on a large group of sedation patients - approximately 2,000 cases at DHMC and 40,000 nation wide in the first year of the study. Many of the cases only take 5-10 minutes to complete. The locations in which these cases are done vary widely. The practitioners vary greatly. The need to obtain informed consent will hugely complicate what is otherwise a straight forward process of collecting a small set of data which is not patient identifiable. D. Research could not practicably be conducted without access to and use of PHI (protected health information) We really are not going to use PHI for this study. The researchers do not need to see PHI. PHI will only be seen if the researcher is also the sedation provider for a given case. E. Adequate plan to protect identifiers from improper use and disclosure Data will be collected under a number system that will only identify the institution, patient care area, and the sequential number that the patient has been enrolled. There will be no indentifying information collected that would allow an individual to trace paitient information collected in this way to the specific patient in question. Once entered into the web-based tool the Dartmouth Bioinformatics Group has provided security for the database. The database will only be accessable to the primary investigator at each institution - protected though the use of passwords and usernames etc. F. Adequate plan to destroy identifiers at the earliest opportunity, unless there is a health or research justification or legal requirement to retain them; and There is no identifyable information on the data collected. G. Adequate written assurances that PHI will not be reused or disclosed for other purposes. No PHI will be collected. How will enrollment in the study change the patient care?: 1. No change in sedation delivery is stipulated by participation in this study.
    • . Risks: There are no known increased risks to the patient because of participation in this study. Just by the fact that data is being collected, some increased attention may be paid to the manner in which sedation is delivered but no adverse effects on sedation would be expected. Risk/Benefit: As stated above, there is no known risk added to this procedure by participation in this study. There are no specific benefits to the patient in participating in this study. Statistical Analysis: Potential Conflict of Interest for Investigator: None References: 1. Lowrie L. Weiss AH, Lacombe C: The pediatric sedation unit: a mechanism for pediatric sedation. Pediatrics. 102(3) E30, 1998 September 2. Green S, Rothrock S, Lynch E et al. Intramuscular ketamine for pediatric sedation in the emergency department: safety profile in 1,022 cases. Ann Emerg Med June 1998; vol 31:688697 3. Schwanda AE, et al. Brief unconscious sedation for painful pediatric oncology procedures. Intravenous methohexital with appropriate monitoring is safe and effective. Am J Pediatr Hematol Oncol. 1993 Nov:15(4):370-6 4. Slonim AD, Ognibene FP. Sedation for pediatric procedures, using ketamine and midazolam, in a primarily adult intensive care unit: a retrospective evaluation. Critical Care Medicine 26(11):1900-4, 1998 5. Malviya S, Voepel-Lewis T, Tait AR. Adverse events and risk factors associated with the sedation of children by non-anesthesiologists. Anesthesia and Analgesia 85:1207-1213, 1997. 6. McCarver, May DG, et. al., Comparison of chloral-hydrate and midazolam for sedation of neonates for neuro-imaging studies. Journal of Pediatrics 128:573-576, 1996. 7. Barst SM, Merola CM, Markowitz AE, Albarracin C, Lebowitz P and Bienkowski RS, A Comparison of propofol and chloral hydrate for sedation of young children during magnetic resonance imaging scans. Paediatric Anaesthesia 4:243-247, 1994. 8. Greenberg SB, Faerber EN and Aspinall CL, High dose chloral hydrate sedation for children undergoing CT. Journal of Computer Assisted Tomography 15:467-469, 1991. 9. Theroux MC, et. al., Efficacy of intranasal midazolam in facilitating suturing of lacerations in preschool children in the emergency department. Pediatrics 91(3)624-627, 1993. 10. Kain ZN, et al., Parental Presence during Induction of Anesthesia versus Sedative Premedication. Anesthesiology 89:1147-56, 1998. 11. US Pharmacopeia. Chloral hydrate overdoses result in children’s deaths. Drug Product Quality Rev.; 33, 1993. 12. Cote CJ, Memorial Children’s Hospital, Chicago, IL; Personal communication, 1999. Committee on Drugs. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatrics 89(6) 1110-1115, 1992. 13. Joint Commission on Accreditation of Healthcare Organizations. Guide to Hospital Accreditation Resources, Department of Anesthesia. 16-17, 1995. 14. Task Force on Sedation and Analgesia by Non-Anesthesiologists. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 84(2) 459-470, 1996.
    • Appendix A: Current List of Participants in the Pediatric Sedation Research Consortium Consortium Directors: Joseph Cravero MD Associate Professor of Anesthesia and Pediatrics Children’s Hospital at Dartmouth Hitchcock Medical Center One Medical Center Drive Lebanon, NH 03756 603-650-2908 Joseph.Cravero@Hitchcock.org George Blike MD George.Blike@Hitchcock.org Participants:
    • 1. Kristine Cieslak, MD Senior attending physician Cook County Children's Hospital Department of Pediatric Emergency Medicine Cook County Children's Hospital Chicago,IL 60612 (312)633-5355 ED (312) 760-0608 page (312) 572-3717 fax klcieslak@aol.com 2. John Berkenbosch, MD Assistant Professor Pediatric Intensivist (Pediatrics background) and Medical Director of our Pediatric Procedural Sedation Service Child Health, Pediatric Critical Care University of Missouri-Columbia One Hospital Dr. Columbia, MO 65212 Phone: 573-882-6544 Fax: 573-882-2742 berkenboschj@health.missouri.edu 3. Kevin M. Creamer M.D. LTC, MC Medical Director of PICU and Pediatric sedation Unit Walter Reed Army Medical Center 6900 Georgia Ave N.W. Washington DC 20307 202-782-2826 Office 202-782-4326 Fax Kevin.Creamer@NA.AMEDD.ARMY.MIL 4. Barry Gelman, M.D. Associate Professor of Clinical Pediatrics University of Miami School of Medicine PO Box 016960 (R131) Miami, FL 33101-6960 305-585-6051 Fax 305-325-0293 BGelman@med.miami.edu 5. James Hertzog, MD Pediatric Intensivist Department of Anesthesiology and Critical Care Medicine Alfred I. duPont Hospital for Children 1600 Rockland Road P.O. Box 269 Wilmington, DE 19899 (302) 651-5390 fax (302) 651-5365 jhertzog@nemours.org Michelle Rhoads, MSN, CRNP Sedation Advanced Practice Nurse Day Medicine Unit Alfred I. duPont Hospital for Children 1600 Rockland Road
    • P.O. Box 269 Wilmington, DE 19899 (302) 651-4530 fax (302) 651-4736 mrhoads@nemours.org 6. Ilan Keidan MD Director, Pediatric Anesthesia Sheba medical center, Tel Aviv University, Israel Fax : +9723-5351565 phone : +97235302754 keidan@012.net.il 7. Cathy R. Lammers, M.D. Director, Pediatric Anesthesiology UC Davis Anesthesiology & Pain Medicine 4150 V Street, Suite 1200 PSSB Sacramento, CA 95817 Tel 916-734-5031 Fax 916-734-7980 crlammers@ucdavis.edu www.anesthesiology.ucdmc.ucdavis.edu 8. Rosemary Orr MD Associate Professor of Anesthesiology and Pediatrics, University of Washington Attending Anesthesiologist and head of Sedation Services Children's Hospital Regional Medical Center Seattle, WA 98105 Tel 206 987 2123/987 2047 rosemary.orr@seattlechildrens 9. David M. Polaner, MD, FAAP Attending Pediatric Anesthesiologist The Children’s Hospital 1056 East 19th Avenue, B090 Denver, CO 80218 Associate Professor of Anesthesiology University of Colorado School of Medicine voice: 303-861-6226 fax: 303-837-2899 polaner.david@tchden.org david.polaner@uchsc.edu 10. Lynne G. Maxwell, MD Department of Anesthesiology/Critical Care Medicine Children's Hospital of Philadelphia #9331 Main 34th St. and Civic Center Blvd. Philadelphia, PA 19104 ph: 215.590.3842 fax: 215.590.1415 email: maxwell@email.chop.edu Maxwell@email.chop.edu 11. Bill Splinter Chief of the Department ofAnesthesiology Children's Hospital of Eastern Ontario
    • 401 Smyth Rd. Ottawa, Ontario, Canada K1H 8L1. 2002-10-01 613-737-2431 Fax number is 613-738-4815. Splinter@exchange.cheo.on.ca 12. Jaap Veerkamp Department of Cariology, Endodontology, Pedodontology Academic Centre Dentistry Amsterdam Louwesweg 1 Amsterdam 1066 EA, the Netherlands phone *31 20 5188470 fax *31 20 5188544 j.veerkamp@acta.nl 13. Marc S. Leder,MD Assistant Professor of Clinical Pediatrics Attending Physician, Pediatric Emergency Medicine Columbus Children's Hospital 700 Children's Drive Columbus, Ohio 43205 Phone: (614) 722-4386 Fax: (614) 722-4380 lederm@pediatrics.ohio-state.edu Jill A. Fitch MD Critical Care Medicine Columbus Children's Hospital 700 Children's Drive Columbus Ohio 43205 Office 614-722-3441 Fax 614-722-3443 Fitchj@pediatrics.ohio-state.edu 14. Stuart E. Lieblich, D.M.D. slieblich3@attbi.com Associate Clinical Professor, University of Connecticut Private Practice, Avon Oral and Maxillofacial Surgery 34 Dale Road Suite 105 Avon, CT 06001 860-674-8079 860-676-8242 fax 15. Dale Steele, MD Associate Professor Department of Pediatrics and Section of Emergency Medicine Brown Medical School Attending Physician and Fellowship Director Pediatric Emergency Medicine Hasbro Children's Hospital Potter 152.1, Rhode Island Hospital 593 Eddy St. Providence, RI 02903 (401)444-5236 - voicemail (401)444-2583 - Fax Dale_Steele@brown.EDU 16. Esther McClure, RN, MSN
    • Nurse Coordinator for Pediatric Sedation Team University of Virginia esther@nexet.net 17. Charlene Cowley, MS, RN, CPNP Pain Management Program Coordinator Phoenix Children's Hospital 1919 E. Thomas Road Phoenix, AZ 85016 Office: 602-546-1537 Pager: 602-817-7403 Fax: 602-546-1533 18. Peter J. Foley, M.D., Ph.D., FAAP Anesthesiology Shriners Hospitals for Children Springfield phone (413) 787-2083 fax (413) 787-2012 pfoley@shrinenet.org 19. David Hirschman, MD Director Pediatric Emergency Medicine University of Minnesota Physicians Pediatric Intensive Care Hennepin County Medical Center dhirschman@pol.net 20. Dr Venu Devabhaktuni, MD, FAAP, FCCP Associate Pediatric Intensivist Chris Evert Childrens Hospital 1600 S Andrews Ave Fort Lauderdale, FL 33316 Ph 954-468-8000 Fax 954-468-8007 venu_devabhaktuni@pediatrix.net Nancy Crego, RN, MSN, CCRN Clinical Nurse Specialist Ph 954-355-5451 Fax 954-468-8010 dizFam@myacc.net 21. Lia Lowrie, MD Medical Director, Pediatric Intensive Care Unit Rainbow Babies and Children's Hospital Associate Professor of Pediatrics Case Western Reserve University School of Medicine Department of Pediatrics Rainbow Babies and Children's Hospital 11100 Euclid Ave. Cleveland, Ohio 44106-6010 Phone: 216-844-3310 Fax: 216-844-3310 lhl3@po.cwru.edu 22. Desmond Henry MD Chairman, Department of Anesthesia
    • Director, Department of Surgical Services The Children’s Hospital henry.desmond@tchden.org 23. Dale F. Szpisjak LCDR, MC, USN Head, Anesthesia Department US Naval Hospital Rota, Spain PSC 819 Box 18-274 FPO, AE 09645-0018 dfszpisjak@rota.med.navy.mil 24. James A. DiNardo, M.D. Senior Associate in Anesthesia Children's Hospital Boston, MA Associate Professor of Anaesthesia Harvard Medical School james.dinardo@TCH.Harvard.edu 25. John C. Brancato, MD Assistant Professor of Pediatrics and Emergency Medicine University of Connecticut School of Medicine Division of Emergency Medicine Connecticut Children's Medical Center Hartford, CT (860) 545-9108 (860) 545-9202 fax