Face, Legs, Activity, Cry, Consolability Behavioral Scale

Instrument Name: Face, Legs, Activity, Cry, Consolability Behavioral Scale

Abbreviation: FLACC

Points for Consideration:

FLACC has a high degree of usefulness for cognitively impaired and many critically ill children; can be used with children who are unable to communicate their pain; always elicit support from parents or carers to help with pain assessment.

Description of Tool:

The Face, Legs, Activity, Cry, Consolability Behavioural Scale (FLACC) is a 5-item ClinRO developed to provide a simple, consistent method for physicians and nurses to identify, document and evaluate postoperative pain in children aged 2 months-7 years. The FLACC tool incorporates five categories of behaviour previously used in other scales. Clinicians are asked to observe legs and body uncovered in patients who are awake for at least 2-5 minutes, or 5 minutes or longer if asleep, and rate the patients behaviour on a 3-level scale. Higher scores represent more severe discomfort and/or pain.

Other Related Tools (if applicable):

The revised Face, Legs, Activity, Cry, Consolability Behavioural Scale.

Categories within the FLACC were unchanged in the revised tool, however, descriptors were added to incorporate those that were most conistently associated with pain in individuals with cognitive impairment.

Minimum Qualification Required by COA Administrator: PhD or MA

Comment:

None

Year: Developed: 1997 Revised: 2008 (specific descriptors associated with pain were incorporated)

Objective of Development:

To evaluate postoperative pain in young children

Population of Development: Age range (therapeutic indication):

Age range: ages 2 months-7 years; 4-19 years with cognitive impairment (Postoperative pain)

Pediatric Population(s) in which COA has been used:

Children with cognitive impairment including cerebral palsy; General population sample of children with pain; Middle ear ventilation; Syndrome with cognitive impairment and Autism.

COA type: ClinRO

Number of Items 5

Mode of Administration: Clinician-rated

Data Collection Mode: Paper and pen or digital administration

Time for Completion: No information

Response Scales: 3-point Likert scale ranging from 0 to 2. Face: 0="Relaxed face, eye contact and interest in surroundings", 1= "Worried look to face, with eyebrows lowered. Eyes partially closed, cheeks raised, mouth pursed", 2="Deep furrows in forehead, with eyes closed, open mouth and deep lines around nose/lips" Legs: 0="Usual tone and motion to limbs (legs and arms)", 1="Increase tone, rigidy, tense, intermittend flexion/extension of limbs", 2="Hyper tonicity, legs pulled tight, exaggerated flexion/extension of limbs, tremors" Activity: 0="Moves easily and freely, normal activity/restrictions", 1="Shifts positions, hesitant to move, guarding, tense torso, pressure on body part", 2="Fixed position, rocking, side-to-side head movement, rubbing body part" Cry: 0="No cry/moan awake or sleep", 1="Occasional moans, cries, whimpers, sighs", 2="Frequent/continuous moans, cries, grunts" Consolability: 0="Calm and does not require consoling", 1="Responds to comfort by touch or talk in 1/2-1 minute", 2="Requires constant comforting or unable to console"

Summary of Scoring:

Available scores: Global score ranging from 0 to 10

Weighting: No

Score Interpretation: Higher score= Severe discomfort and/or pain.

Evidence of Literature Review: Yes (revised FLACC)

Evidence of Instrument Review: Yes (original FLACC)

Evidence of Clinical or Expert Input: Yes (original and revised FLACC)

Evidence of concept elicitation in target patient population: Yes (revised FLACC)

Evidence of a Saturation Grid: None identified

Evidence for Selection of Data Collection Method: None identified

Recall/Observation Period: Present time (2-5 minutes observation if patient is awake, 5 minutes obseravtion or longer if patient is asleep)

Evidence for Selection of Reponse Options: None identified

Evidence of cognitive interviewing of draft instrument in target patient population: None identified

Evidence of Preliminary Scoring of Items and Domains: None identified

Evidence related to respondent and administrator burden: None identified

Evidence of a Conceptual Framework: None identified

Evidence of an item-tracking matrix: None identified

Evidence related to item selection: None identified

Evidence of re-testing the final version: None identified

Internal consistency (Cronbach's alpha): None identified

Evidence of internal consistency: None identified

Test-retest Reliability (ICC):

Malviya S (2006)
Test-retest reliability
ICC=0.97 (CI=0.92 to 0.99)
Was a definition of stability applied to identify stable patients: No
Time frame between the two administrations: 2-3 weeks
Population/Disease: Childen (aged 4-19 years) with cognitive impairment and acute postoperative pain; n=52

Inter-rater/ inter-interviewer reliability (kappa):

Merkel SI (1997)
Interrater reliability
- Correlation Coefficient used: not stated. Reliability for the FLACC scores was r[87]=0.94; p<0.001, 69%, 0.52 for the Face, 87%, 0.67 for Legs, 89%, 0.72 for Activity, 91%, 0.82 for Cry and 78%, 0.66 for Consolability subscales - Population/Disease: Children aged 2-7 months who had undergone a variety of elective surgical procedures; n=30 Malviya S (2006) Interrater reliability - Correlation Coefficient used: Spearman's p, ICC and % agreement with kappa statistics. Face: ICC=0.86 (0.83–0.89); p<0.001; % agreement (k)=53–81 (0.57) Legs: ICC=0.77 (0.70–0.83); p<0.001; % agreement (k)=46–86 (0.44) Activity: ICC=0.75 (0.68–0.80); p<0.001; % agreement (k)=50–78 (0.45) Cry: ICC=0.87 (0.83–0.89); p<0.001; % agreement (k)= 46–89 (0.55) Consolability: ICC=0.76 (0.70–0.81); p<0.001; % agreement (k)= 64–82 (0.48) Total score: ICC=0.90 (0.87–0.92); p<0.001; % agreement (k)=NA Coded pain scores (mild 0-3, moderate 4-6 and severe 7-10): ICC=0.83 (0.78–0.86); p<0.001; % agreement (k)=35–89 (0.50) Children with spasticity: Legs and activity: 42-84% (k=0.41) Children without spasticity: Legs and activity: 33-89% (k=0.53) - Population/Disease: Children (aged 4-19 years) with cognitive impairment and acute postoperative pain; n=52

Evidence of test-retest or inter-rater reliability: Yes

Concurrent validity (convergent, divergent):

Merkel SI (1997)
- Correlation coefficient used: Pearson's r
- Measures:FLACC; Global rating of pain; Objective Pain Scale (OPS)
- Results:
FLACC and global ratings of pain: (r[47]=0.41; p>0.005)
FLACC and OPS: (r=.80; p>0.001)
- Population/Disease: Children aged 2-7 months who had undergone a variety of elective surgical procedures; n=29

Malviya S (2006)
Correlation coefficient used: Spearman's p
Measures: nurse-rated FLACC bedside observer; FLACC bedside observer; FLACC video observer; parent-rated 0-10 Visual Analog Scale (VAS) (0=no pain to 10=worst possible pain); child self-reported pain score using a 0-10 numbers scale, simplified faces scale, or a simple word scale (small, medium, big pain); Nursing Assessment of Pain Intensity (NAPI) video observer.
Results:
Nurse FLACC and parent: 0.74 (p<0.01) Nurse FLACC and child: 0.78 (p<0.01) Nurse FLACC and NAPI: 0.78 (p<0.01) Bedside FLACC and parent: 0.82 (p<0.01) Bedside FLACC and child: 0.86 (p<0.01) Bedside FLACC and NAPI: 0.87 (p<0.01) Video observer FLACC and parent: 0.65 (p<0.01) Video observer FLACC and child: 0.86 (p=0.051) Video observer FLACC and NAPI31/10/2024 0.78 (p<0.01) Population/Disease: Childen (aged 4-19 years) with cognitive impairment and acute postoperative pain; n=52

Known-group validity:

None identified

Evidence of Translatability Assessment: None identified

Evidence related to missing data: None identified

Evidence for Selection of Recall Period: None identified

Evidence of Administration Instructions and Training Provided: Yes

Evidence of concurrent validity: Yes

Evidence of known-groups validity: None identified

Evidence of ability to detect change over time: Yes

Ability to detect change (Responsiveness):

Merkel SI (1997)
- Method: n=29 children were observed and assigned FLACC scores immediately prior to opioid analgesic administration and again at 10, 30 and 60 minute intervals after intraveneous opiates, or at 30 and 60 minutes after oral acetaminophen or oral codeine.
- Results:
Preanalgesia FLACC scores: (7.0 {+ or -} 2.9) were significantly higher (p<0.001) than 10 minutes postanalgesia (1.7 {+ or -} 2.2), 30 minutes postanalgesia (1.0 {+ or -} 1.9) and 60 minutes postanalgesia (0.2 {+ or -} 0.5). No significant differences were observed between 10, 30 and 60 minute scores. - Population/Disease: Children aged 2-7 months who had undergone a variety of elective surgical procedures; n=29 Malviya S (2006) - Method: n=52 children were observed and assigned FLACC scores by nurses (bedside observers and video observers) using the revised and individualized FLACC pain tool following emergence from general anesthesia and 30 minutes following analgesic administration. - Results: FLACC scores significantly decreased following analgesic administration for bedside nurses' assigned scores (n=20; 6.1 +/- 2.5 vs 2.2 +/-2.4; p<0.001) and video observer's scores (n=20; 6.1 +/- 2.6 vs 1.9 +/- 2.7; p<0.001). Parent-assigned pain scores using a global pain rating (0-10) similarly decreased (n=12; 6.6 +/- 2.4 vs 2.6; p=0.003) - Population/Disease: Childen (aged 4-19 years) with cognitive impairment and acute postoperative pain; n=52

Responder Thresholds:

None identified

Evidence of responder thresholds: None identified

Merkel, S. I., Voepel-Lewis, T., Shayevitz, J. R., & Malviya, S. (1997). The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatric nursing, 23(3), 293–297. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/9220806/

Malviya, S., Voepel-Lewis, T., Burke, C., Merkel, S., & Tait, A. R. (2006). The revised FLACC observational pain tool: improved reliability and validity for pain assessment in children with cognitive impairment. Paediatric anaesthesia, 16(3), 258–265. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/16490089/

Nursing guidelines: https://www.rch.org.au/rchcpg/hospital_clinical_guideline_index/Pain_Assessment_and_Measurement/

Digital version of measure: https://www.mdcalc.com/calc/10545/face-legs-activity-cry-consolability-flacc-scale#why-use

Product label search: https://eprovide.mapi-trust.org/advanced-search?search=Face,%20Legs,%20Activity,%20Cry,%20Consolability%20Behavioral%20Scale&database=prolabels

Regulatory endorsement: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-development-medicinal-products-intended-treatment-pain-second-draft_en.pdf

Yes

Agency: FDA
Device: Tula® System.
Approval date: 24-Nov-2019
Therapeutic indication: Middle ear ventilation
COA results: Primary endpoint
Age: 6 months-12 years

Yes

Original language: English for the USA

Translations (PROQOLID): 15 translations (not specified)

None identified

Authors: Merkel S; Voepel-Lewis T; Shayevitz JR; Malviya S

Contact: No information

© 2002, The Regents of the University of Michigan. All rights reserved

None identified

https://www.mdcalc.com/calc/10545/face-legs-activity-cry-consolability-flacc-scale