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CARE--Childhood Awareness and Recall Evaluation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00308984
First received: March 28, 2006
Last updated: March 6, 2012
Last verified: March 2012
  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

Further study details as provided by Covidien:

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

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Covidien
Investigators
Principal Investigator: Shobha Malviya, MD University of Michigan
  More Information

Publications:
Lopez U, Iselin-Chavez I, Habre W. Incidence of awareness during general anaesthesia in children. Br J Anaesth. 2004; 93(3):490P-491P.

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT00308984     History of Changes
Other Study ID Numbers: 225
Study First Received: March 28, 2006
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
Pediatrics
Intraoperative Awareness
Pediatric Anesthesia

ClinicalTrials.gov processed this record on November 20, 2014