CARE--Childhood Awareness and Recall Evaluation

NCT00308984 | Completed

• 1 other identifier: 225
• Study Type: observational
• Target: 1,784
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Anesthesia

Keywords

Pediatrics; Intraoperative Awareness; Pediatric Anesthesia

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children 5-15 years of age scheduled for a surgical procedure that requires general anesthesia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (3)

The Children's Hospital, University of Colorado School of Medicine

Denver, Colorado, 80218, United States

Location

Children's Hospital of Atlanta at Egleston, Emory University

Atlanta, Georgia, 30322, United States

Location

Mott Children's Hospital, University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (17)

• 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. doi: 10.1111/j.1399-6576.2004.00260.x.

  PMID: 14674969 BACKGROUND

• 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. doi: 10.1093/oxfordjournals.bja.a013383.

  PMID: 10740539 BACKGROUND

• Sandin RH, Enlund G, Samuelsson P, Lennmarken C. Awareness during anaesthesia: a prospective case study. Lancet. 2000 Feb 26;355(9205):707-11. doi: 10.1016/S0140-6736(99)11010-9.

  PMID: 10703802 BACKGROUND

• 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):833-839. doi: 10.1213/01.ANE.0000130261.90896.6C.

  PMID: 15333419 BACKGROUND

• 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. doi: 10.1016/S0140-6736(04)16300-9.

  PMID: 15172773 BACKGROUND

• Moerman N, Bonke B, Oosting J. Awareness and recall during general anesthesia. Facts and feelings. Anesthesiology. 1993 Sep;79(3):454-64. doi: 10.1097/00000542-199309000-00007.

  PMID: 8363069 BACKGROUND

• Lennmarken C, Bildfors K, Enlund G, Samuelsson P, Sandin R. Victims of awareness. Acta Anaesthesiol Scand. 2002 Mar;46(3):229-31. doi: 10.1034/j.1399-6576.2002.t01-1-460301.x.

  PMID: 11939910 BACKGROUND

• Klafta JM, Roizen MF. Current understanding of patients' attitudes toward and preparation for anesthesia: a review. Anesth Analg. 1996 Dec;83(6):1314-21. doi: 10.1097/00000539-199612000-00031.

  PMID: 8942605 BACKGROUND

• Preventing, and managing the impact of, anesthesia awareness. Sentinel Event Alert. 2004 Oct 6;(32):1-3. No abstract available.

  PMID: 15470805 BACKGROUND

• McKie BD, Thorp EA. Awareness and dreaming during anaesthesia in a paediatric hospital. Anaesth Intensive Care. 1973 Aug;1(5):407-14. doi: 10.1177/0310057X7300100507. No abstract available.

  PMID: 4761535 BACKGROUND

• Hobbs AJ, Bush GH, Downham DY. Peri-operative dreaming and awareness in children. Anaesthesia. 1988 Jul;43(7):560-2. doi: 10.1111/j.1365-2044.1988.tb06687.x.

  PMID: 3414918 BACKGROUND

• Ranta SO, Laurila R, Saario J, Ali-Melkkila T, Hynynen M. Awareness with recall during general anesthesia: incidence and risk factors. Anesth Analg. 1998 May;86(5):1084-9. doi: 10.1097/00000539-199805000-00035.

  PMID: 9585303 BACKGROUND

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

  BACKGROUND

• 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):653-661. doi: 10.1213/01.ANE.0000150604.73481.00.

  PMID: 15728046 BACKGROUND

• 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):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.

  PMID: 15562048 BACKGROUND

• 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. doi: 10.1001/archpedi.1996.02170370016002.

  PMID: 8953995 BACKGROUND

• 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.

  PMID: 19713260 RESULT

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shobha Malviya, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2006
• First Posted: March 30, 2006
• Study Start: January 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: May 1, 2008
• Last Updated: March 7, 2012

Record last verified: 2012-03

Locations

US (3)