Multicent er Prospectiv e Analysis of
Pediatric Sedation Practice – The
Pediatric Sedation Research Consortium
Principal Investigat or : Joseph P. Cravero MD
Primary Contacts : George T. Blike MD
Purpos e : 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.
Hypoth e si s: 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 adequat e 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 manage m e nt 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 departm ents). 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 departm ent. 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 improvem ent 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
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 Cot é 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 inadequat e 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 developm ent of better
practice protocols for pediatric sedation.
Why this study is different than previou s investi gation s? : 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 :
Stud y Type: Prospective survey of pediatric sedation practice involving collection
of data from (approximately) approximately 22 member institutions over the period
of one year.
Metho d : 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
1) Patient number (for the institution)
2) Patient age
3) Patient weight
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
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 adequat e? (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.
Outcom e 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)
Timetabl e : The time required to complete the study should be approximately
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
Recruitme n t : 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.
Comp et e n c y : N/A
Informed Consen t:
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
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
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
usernam es 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
No PHI will be collected.
How will enrollmen t in the study chang e 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/Ben efit : 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.
Potential Conflict of Interest for Investi gat or : None
Referenc e s :
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.;
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-
Current List of Participant s in the Pediatric Sedation Research
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
George Blike MD
1. Kristine Cieslak, MD
Senior attending physician
Cook County Children's Hospital
Department of Pediatric Emergency Medicine
Cook County Children's Hospital
(312)633- 5355 ED
(312) 760- 0608 page
(312) 572- 3717 fax
2. John Berkenbosch, MD
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
3. Kevin M. Creamer M.D.
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
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
5. James Hertzog, MD
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
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
6. Ilan Keidan MD
Director, Pediatric Anesthesia
Sheba medical center, Tel Aviv University, Israel
Fax : +9723- 5351565
phone : +97235302754
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
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
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
10. Lynne G. Maxwell, MD
Department of Anesthesiology/Critical Care Medicine
Children's Hospital of Philadelphia
34th St. and Civic Center Blvd.
Philadelphia, PA 19104
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.
12. Jaap Veerkamp
Department of Cariology, Endodontology, Pedodontology
Academic Centre Dentistry Amsterdam
Amsterdam 1066 EA, the Netherlands
phone *31 20 5188470
fax *31 20 5188544
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
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
14. Stuart E. Lieblich, D.M.D.
Associate Clinical Professor, University of Connecticut
Private Practice, Avon Oral and Maxillofacial Surgery
34 Dale Road
Avon, CT 06001
860- 674- 8079
860- 676- 8242 fax
15. Dale Steele, MD
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
16. Esther McClure, RN, MSN
Nurse Coordinator for Pediatric Sedation Team
University of Virginia
17. Charlene Cowley, MS, RN, CPNP
Pain Managem ent 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
Shriners Hospitals for Children
phone (413) 787- 2083
fax (413) 787- 2012
19. David Hirschman, MD
Director Pediatric Emergency Medicine
University of Minnesota Physicians
Pediatric Intensive Care
Hennepin County Medical Center
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
Nancy Crego, RN, MSN, CCRN
Clinical Nurse Specialist
Ph 954- 355- 5451
Fax 954- 468- 8010
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
22. Desmond Henry MD
Chairman, Department of Anesthesia
Director, Department of Surgical Services
The Children’s Hospital
23. Dale F. Szpisjak
LCDR, MC, USN
Head, Anesthesia Department
US Naval Hospital Rota, Spain
PSC 819 Box 18- 274
24. James A. DiNardo, M.D.
Senior Associate in Anesthesia
Associate Professor of Anaesthesia
Harvard Medical School
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
(860) 545- 9108
(860) 545- 9202 fax