Welcome to NGC. Skip directly to: Search Box, Navigation, Content.


Brief Summary

GUIDELINE TITLE

Practice parameter: antiepileptic drug prophylaxis in severe traumatic brain injury: report of the Quality Standards Subcommittee of the American Academy of Neurology.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • December 12, 2007, Carbamazepine: The U.S. Food and Drug Administration (FDA) has provided recommendations for screening that should be performed on specific patient populations before starting treatment with carbamazepine.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Definitions for the strength of the recommendations (Level A, B, C, U) and classification of evidence (Class I-IV) are provided at the end of the "Major Recommendations" field.

Practice Recommendations

For adult patients with severe traumatic brain injury (TBI) (typically with prolonged loss of consciousness or amnesia, intracranial hematoma or brain contusion on computed tomography [CT] scan, and/or depressed skull fracture):

  • Prophylactic treatment with phenytoin, beginning with an intravenous (IV) loading dose, should be initiated as soon as possible after injury to decrease the risk of post-traumatic seizures occurring within the first 7 days (Level A).
  • Prophylactic treatment with phenytoin, carbamazepine, or valproate should not routinely be used beyond the first 7 days after injury to decrease the risk of post-traumatic seizures occurring beyond that time (Level B).

These recommendations are generally consistent with those from other national specialty organizations, as well as with the findings on post-traumatic seizures from a recent meta-analysis (as of 2001) of antiepileptic drug (AED) prophylactic effect in a variety of epileptogenic conditions.

Definitions:

Strength of Recommendations

Level A: Established as effective, ineffective, or harmful for the given condition in the specified population. Usually, an "A" recommendation requires that the pooled result from two or more distinct class I studies demonstrates a consistent, significant, and important effect.

Level B: Probably effective, ineffective, or harmful for the given condition in the specified population. Usually, a "B" recommendation requires that a single class I study demonstrates a significant and important effect or the pooled result from two or more distinct class II studies demonstrates a consistent, significant, and important effect.

Level C: Possibly effective, ineffective, or harmful for the given condition in the specified population. Usually, a "C" recommendation requires that a single class II study demonstrates a significant and important effect or the pooled result of two or more distinct class III studies demonstrates a consistent, significant, and important effect.

Level U: Data are inadequate or conflicting. Given current knowledge, treatment is unproven and an evidence-based recommendation cannot be made.

Classification of Evidence

Class I: Evidence provided by a randomized, controlled clinical trial (RCT) with masked outcome assessment in a representative population. The following are required: a) primary outcomes are clearly defined; b) exclusion and inclusion criteria are clearly stated; c) there is adequate accounting of dropouts and crossovers with numbers sufficiently low to have minimal potential for bias; and d) relevant baseline characteristics are substantially equivalent among treatment groups. For the purposes of this parameter, a loss-to-follow-up rate of <10% was required to meet criterion c.

Class II: Evidence provided by a prospective matched group cohort study in a representative population with masked outcome assessment that meets a through d above or an RCT that lacks one criterion a through d.

Class III: All other controlled trials (including well-defined natural history controls or patients serving as their own controls) in a representative population where outcome assessment is independent of patient treatment.

Class IV: Evidence from studies not assessing outcomes independent of treatment, uncontrolled studies, case series, case reports, or expert opinion.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2003 Jan 14

GUIDELINE DEVELOPER(S)

American Academy of Neurology - Medical Specialty Society

SOURCE(S) OF FUNDING

American Academy of Neurology (AAN)

GUIDELINE COMMITTEE

Quality Standards Subcommittee of the American Academy of Neurology

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

AAN Quality Standards Subcommittee Members: Gary Franklin, MD, MPH (Co-Chair); Catherine Zahn, MD (Co-Chair); Milton Alter, MD, PhD; Stephen Ashwal, MD; Richard M. Dubinsky, MD; Jacqueline French, MD; Gary Friday, MD; Michael Glantz, MD (Facilitator); Gary Gronseth, MD; Deborah Hirtz, MD; Robert G. Miller, MD; David J. Thurman, MD, PhD; and William Weiner, MD

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: A list of American Academy of Neurology (AAN) guidelines, along with a link to a Portable Document Format (PDF) file for this guideline, is available at the AAN Web site.

Print copies: Available from the AAN Member Services Center, (800) 879-1960, or from AAN, 1080 Montreal Avenue, St. Paul, MN 55116.

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

NGC STATUS

This summary was completed by ECRI on February 6, 2004. This summary was updated by ECRI Institute on January 10, 2008, following the U.S. Food and Drug Administration advisory on Carbamazepine.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is copyrighted by the American Academy of Neurology.

DISCLAIMER

NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion.aspx .

NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
DHHS Logo