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 nonstandardized 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 1020%. (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)
2)
3)
4)
5)
6)
7)
8)
9)
10)
11)
12)
13)
14)
15)
16)
Patient number (for the institution)
Patient age
Patient weight
Sex
Coexisting medical problems or issues
Procedure to be performed
Medication(s) used and route of delivery
Monitoring present during the procedure
Type of provider delivering sedation (RN, MD etc – and specialty training as appropriate
Sedation achieved successfully for the procedure – yes or no
Time required from starting sedation med to induction of sedation.
Child calm and still for procedure or were the conditions adequate? (yes or no)
Time from end of the procedure to discharge (mins)
Side effects of sedation (nausea, vomiting, delirium)
Adverse events (oxygen desaturation, apnea, need for hospitalization, death)
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