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CARE--Childhood Awareness and Recall Evaluation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00308984
First Posted: March 30, 2006
Last Update Posted: March 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic - MITG
  Purpose

The purpose of this study is to describe the incidence of recall or awareness under anesthesia in children aged 5-15 by collecting anesthetic and post-operative follow-up data relating to intra-operative recall during general anesthesia.

The hypothesis is that the implementation of routine awareness follow-up evaluation in children undergoing general anesthesia will identify that the incidence of intra-operative awareness in children is equal to or greater than in adults.


Condition Phase
Anesthesia Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Center Study on the Incidence of Intra-operative Awareness and Recall in the Pediatric Population Undergoing General Anesthesia: CARE--Childhood Awareness and Recall Evaluation

Resource links provided by NLM:


Further study details as provided by Medtronic - MITG:

Enrollment: 1784
Study Start Date: January 2006
Study Completion Date: May 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Awareness, or the unwanted recall of intra-operative events occurring during general anesthesia, is a potentially avoidable anesthetic complication that poses the risk for psychological sequelae. While the reported incidence is 0.1-0.2% in adults, this translates to > 20,000 cases of awareness occurring in adults annually in the United States (Ekman, 2004; Myles, 2000; Sandin, 2000; Sebel, 2004; Myles, 2004). Patients who experience recall may subsequently exhibit post-traumatic stress and psychological symptoms (Sebel, 2004; Myles, 2004; Moerman, 1993; Lennmarken, 2002). Furthermore; studies have shown that up to 54% of adult patients worry about the possibility of awareness during surgery (Klafta, 1996). Subsequent to the recent studies on unintended intraoperative awareness and published data on the impact of Bispectral Index in preventing and detecting anesthesia awareness, the Joint Commission on Accreditation of Healthcare Organizations has classified intraoperative awareness as a sentinel event (2004).

Limited data are available regarding the incidence and consequences of awareness in children. Studies which are available have identified a significantly higher incidence of intraoperative recall in children than has been shown in adults. McKie reported an incidence of 5% factual recall in 202 patients aged 7-14 years in 1973 (1973). The incidence of dreaming was reported as 11%. Hobbs, in 1988, reported a 19% incidence of dreaming and no awareness in 120 pediatric patients who received the "Liverpool anesthetic technique" (N20, O2, relaxant). Ranta reported 0.4% awareness in 4800 patients aged 12 years or older, with the youngest patient demonstrating undisputed awareness at 20 years of age (1998). More recently, Lopez et. al., found an 8% incidence of awareness in children 6-16 years of age, with a significant relationship between multiple attempts to secure the airway and the likelihood of awareness (2004). Most recently, a study published in 2005 by Davidson, et. al., found an incidence of 0.8% in 864 children aged 5-12 years of age with general anesthesia as is practiced in Australia. Likely explanations for more frequent awareness in children include altered anesthetic pharmacology in children and differences in the practice of pediatric anesthesia.

Post-operative behavior changes including emergence delirium, general anxiety, nighttime crying, enuresis, separation anxiety and temper tantrums have been described to occur up in to 50% of children undergoing surgery (Kain, 1996). Studies have also shown a correlation between pre-operative anxiety levels of both the child and parents, and may result in a greater risk of emergence delirium and later maladaptive behaviors. These results have not demonstrated a cause-effect relationship (Kain, 2004). Evaluating for intra-operative awareness or unwanted recall of intra-operative events with or without depth of anesthesia monitoring, may add to the knowledge base for causal factors in postoperative maladaptive behavior changes in the pediatric population.

The JCAHO Sentinel Event Alert, Issue 32, dated October 6, 2004, describes recommendations for health care organizations which perform procedures under general anesthesia, for the prevention and detection of intra-operative awareness. Specific recommendations include: identification of patients who are at higher risk for intraoperative awareness, appropriate follow-up of all patients, including children, who have undergone general anesthesia, and identification, management and, if appropriate, referral of patients who have experienced awareness.

Since little data exists on the incidence and identification of intra-operative awareness in children, this multi-center, prospective, observational, cohort evaluation is being conducted to describe and evaluate the incidence of awareness during routine general anesthetic practice in children. Following IRB approved informed consent (and assent as appropriate), children will sequentially be enrolled to participate in the study. Participating institutions will share de-identified data of enrolled pediatric patients undergoing general anesthesia. Each center will collect and maintain patient data in compliance with all privacy and institutional guidelines.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children 5-15 years of age scheduled for a surgical procedure that requires general anesthesia
Criteria

Inclusion Criteria:

  • Children 5-15 years of age scheduled for a surgical procedure that requires general anesthesia.
  • Children able to respond to and answer post-operative follow-up questions at 3 time intervals post anesthesia: prior to discharge from the post-operative recovery area (or within the first 24 hours following surgery as clinically indicated), 3 (+ 1) days and 14 (+ 2) days post-operatively.
  • Ability to speak and understand English.
  • Anticipated length of general anesthesia of at least 30 minutes.

Exclusion Criteria:

  • Children with known cognitive or neurologic impairment, psychiatric illness or developmental delay consistent with inability to accurately or adequately respond to or answer post-operative follow-up recall questions relating to their anesthesia experience.
  • Expectation that the child will remain endotracheally intubated beyond 24 hours postoperatively.
  • Anticipated use of ketamine for anesthetic management.
  • Children that have had surgery or general anesthesia within the past 6 months or it is anticipated that child will require additional surgeries within the 14 day study follow-up time period.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308984


Locations
United States, Colorado
The Children's Hospital, University of Colorado School of Medicine
Denver, Colorado, United States, 80218
United States, Georgia
Children's Hospital of Atlanta at Egleston, Emory University
Atlanta, Georgia, United States, 30322
United States, Michigan
Mott Children's Hospital, University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Medtronic - MITG
Investigators
Principal Investigator: Shobha Malviya, MD University of Michigan
  More Information

Publications:
Malviya S, Galinkin JL, Bannister CF, Burke C, Zuk J, Popenhagen M, Brown S, Voepel-Lewis T. The incidence of intraoperative awareness in children: childhood awareness and recall evaluation. Anesth Analg. 2009 Nov;109(5):1421-7. doi: 10.1213/ANE.0b013e3181b620b0. Epub 2009 Aug 27.
Ekman A, Lindholm ML, Lennmarken C, Sandin R. Reduction in the incidence of awareness using BIS monitoring. Acta Anaesthesiol Scand. 2004 Jan;48(1):20-6.
Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth. 2000 Jan;84(1):6-10.
Sandin RH, Enlund G, Samuelsson P, Lennmarken C. Awareness during anaesthesia: a prospective case study. Lancet. 2000 Feb 26;355(9205):707-11.
Sebel PS, Bowdle TA, Ghoneim MM, Rampil IJ, Padilla RE, Gan TJ, Domino KB. The incidence of awareness during anesthesia: a multicenter United States study. Anesth Analg. 2004 Sep;99(3):833-9, table of contents.
Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63.
Moerman N, Bonke B, Oosting J. Awareness and recall during general anesthesia. Facts and feelings. Anesthesiology. 1993 Sep;79(3):454-64.
Lennmarken C, Bildfors K, Enlund G, Samuelsson P, Sandin R. Victims of awareness. Acta Anaesthesiol Scand. 2002 Mar;46(3):229-31.
Klafta JM, Roizen MF. Current understanding of patients' attitudes toward and preparation for anesthesia: a review. Anesth Analg. 1996 Dec;83(6):1314-21. Review.
Preventing, and managing the impact of, anesthesia awareness. Sentinel Event Alert. 2004 Oct 6;(32):1-3.
McKie BD, Thorp EA. Awareness and dreaming during anaesthesia in a paediatric hospital. Anaesth Intensive Care. 1973 Aug;1(5):407-14.
Hobbs AJ, Bush GH, Downham DY. Peri-operative dreaming and awareness in children. Anaesthesia. 1988 Jul;43(7):560-2.
Ranta SO, Laurila R, Saario J, Ali-Melkkilä T, Hynynen M. Awareness with recall during general anesthesia: incidence and risk factors. Anesth Analg. 1998 May;86(5):1084-9.
Lopez U, Iselin-Chavez I, Habre W. Incidence of awareness during general anaesthesia in children. Br J Anaesth. 2004; 93(3):490P-491P.
Davidson AJ, Huang GH, Czarnecki C, Gibson MA, Stewart SA, Jamsen K, Stargatt R. Awareness during anesthesia in children: a prospective cohort study. Anesth Analg. 2005 Mar;100(3):653-61, table of contents.
Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-54, table of contents.
Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45.

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00308984     History of Changes
Other Study ID Numbers: 225
First Submitted: March 28, 2006
First Posted: March 30, 2006
Last Update Posted: March 7, 2012
Last Verified: March 2012

Keywords provided by Medtronic - MITG:
Pediatrics
Intraoperative Awareness
Pediatric Anesthesia


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