Protocol - Pain Intensity - Toddler
This revised Face, Legs, Activity, Cry, Consolability (FLACC) pain tool rates pain intensity using five different categories on a scale from 0 to 2. Observations of a participant’s behavior are then recorded and compared to descriptors listed in each category and then scored. This protocol was validated in individuals aged 4–21 years old with a cognitive impairment.
The Sickle Cell Disease Pain Working Group notes that the revised Face, Legs, Activity, Cry, Consolability (FLACC) pain tool can also be used for children between 1 year and 4 years old, as well as individuals with cognitive impairment or who are nonverbal.
The parent of the participant can be helpful in providing baseline status, this is especially important for those individuals with a cognitive impairment.
REVISED FLACC Scale
|Face||No particular expression or smile.||Occasional grimace or frown; withdrawn or disinterested; appears sad or worried.||Consistent grimace or frown; frequent/constant quivering chin, clenched jaw; distressed-looking face; expression of fright or panic.|
|Legs||Normal position or relaxed; usual tone and motion to limbs.||Uneasy, restless, tense; occasional tremors.||Kicking, or legs drawn up; marked increase in spasticity, constant tremors or jerking.|
|Activity||Lying quietly, normal position, moves easily; regular, rhythmic respirations.||Squirming, shifting back and forth, tense or guarded movements; mildly agitated (e.g., head back and forth, aggression); shallow, splinting respirations, intermittent sighs||Arched, rigid or jerking; severe agitation; head banging; shivering (not rigors); breath holding, gasping, or sharp intake of breaths, severe splinting.|
|Cry||No cry/verbalization||Moans or whimpers; occasional complaint; occasional verbal outburst or grunt||Crying steadily, screams or sobs, frequent complaints; repeated outbursts, constant grunting.|
|Consolability||Content and relaxed||Reassured by occasional touching, hugging, or being talked to. Distractible||Difficult to console or comfort; pushing away caregiver, resisting care or comfort measures.|
Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0–2, which results in a total score between zero and ten. Revised FLACC scores coded as: mild (scores 0–3), moderate (4–6), and severe (7–10).
Personnel and Training Required
|Specialized requirements for biospecimen collection||No|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Child, Adolescent, Adult
Individuals aged 4–21 years with cognitive impairment
The Face, Legs, Activity, Cry, Consolability (FLACC) pain tool is able to measure pain intensity of individuals with cognitive impairment or who are nonverbal, as well as children aged 1–4 years and can be scaled to older ages.
|caDSR Common Data Elements (CDE)||Pain Intensity Scale-Child Face, Legs, Activity, Cry, Consolability Scale Face Score||10496918||CDE Browser|
|caDSR Common Data Elements (CDE)||Pain Intensity Scale-Child Face, Legs, Activity, Cry, Consolability Scale Leg Score||10496919||CDE Browser|
|caDSR Common Data Elements (CDE)||Pain Intensity Scale-Child Face, Legs, Activity, Cry, Consolability Scale Activity Score||10496920||CDE Browser|
|caDSR Common Data Elements (CDE)||Pain Intensity Scale-Child Face, Legs, Activity, Cry, Consolability Scale Crying Score||10496921||CDE Browser|
|caDSR Common Data Elements (CDE)||Pain Intensity Scale-Child Face, Legs, Activity, Cry, Consolability Scale Consolable Score||10497042||CDE Browser|
|caDSR Common Data Elements (CDE)||Derived Pain Intensity Scale-Child Face, Legs, Activity, Cry, Consolability Scale Total Score||10496922||CDE Browser|
Process and Review
Protocol Name from Source
Revised Face, Legs, Activity, Cry, Consolability (FLACC) Pain Tool
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. Pediatric Anesthesia, 16(3), 258–265. https://doi.org/10.1111/j.1460-9592.2005.01773.x
Adegoke, O. A., Adegoke, S. A., Okeniyi, J. A., & Smith, O. S. (2013). Serum cardiac troponin T (cTnT) in Nigerian children with sickle cell anaemia: An index of myocardial injury. International Journal of Medicine and Medical Sciences, 3(2), 376–380.
Chang, J., Versloot, J., Fashler, S. R., McCrystal, K. N., & Craig, K. D. (2015). Pain assessment in children: Validity of facial expression items in observational pain scales. Clinical journal of pain, 31(3), 189–197. https://doi.org/10.1097/AJP.0000000000000103
Choueiry, J., Reszel, J., Hamid, J. S., Wilding, J., Martelli, B., & Harrison, D. (2020). Development and pilot evaluation of an educational tool for the FLACC pain scale. Pain Management Nursing, 21(6), 523–529. https://doi.org/10.1016/j.pmn.2020.06.002
Crellin, D. J., Harrison, D., Santamaria, N., & Babl, F. E. (2015). Systematic review of the Face, Legs, Activity, Cry and Consolability scale for assessing pain in infants and children: Is it reliable, valid, and feasible for use? Pain, 156(11), 2132–2151. https://doi.org/10.1097/j.pain.0000000000000305
Diaz-Hennessey, S., & O’Shea, E. R. (2019). Virtual reality: Augmenting the acute pain experience in children. Pediatric Nursing, 45(3), 122–127.
Ender, K. L., Krajewski, J. A., Babineau, J., Tresgallo, M., Schechter, W., Saroyan, J. M., & Kharbanda, A. (2014). Use of a clinical pathway to improve the acute management of vaso-occlusive crisis pain in pediatric sickle cell disease. Pediatric Blood & Cancer, 61(4), 693–696. https://doi.org/10.1002/pbc.24864
Fox, M. A., Ayyangar, R., Parten, R., Haapala, H. J., Schilling, S. G., & Kalpakjian, C. Z. (2019). Self-report of pain in young people and adults with spastic cerebral palsy: Interrater reliability of the revised Face, Legs, Activity, Cry, and Consolability (r-FLACC) scale ratings. Developmental Medicine and Child Neurology, 61(1), 69–74. https://doi.org/10.1111/dmcn.13980
Heeney, M. M., Abboud, M. R., Amilon, C., Andersson, M., Githanga, J., Inusa, B., Kanter, J., Leonsson-Zachrisson, M., Michelson, A. D., & Berggren, A. R.; HESTIA3 Study Investigators (2019). Ticagrelor versus placebo for the reduction of vaso-occlusive crises in pediatric sickle cell disease: Rationale and design of a randomized, double-blind, parallel-group, multicenter phase 3 study (HESTIA3). Contemporary Clinical Trials, 85, 105835. https://doi.org/10.1016/j.cct.2019.105835
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.
Michaleff, Z. A., Kamper, S. J., Stinson, J. N., Hestbaek, L., Williams, C. M., Campbell, P., & Dunn, K. M. (2017). Measuring musculoskeletal pain in infants, children, and adolescents. Journal of Orthopaedic and Sports Physical Therapy, 47(10), 712–730. https://doi.org/10.2519/jospt.2017.7469
Pedersen, L. K., Rahbek, O., Nikolajsen, L., & Møller-Madsen, B. (2015). The revised FLACC score: Reliability and validation for pain assessment in children with cerebral palsy. Scandinavian Journal of Pain, 9(1), 57–61. https://doi.org/10.1016/j.sjpain.2015.06.007
Shams, T., Al Wadani, H., El-Masry, R., & Zakaria, O. (2014). Effect of prophylactic vitamin D on anesthetic outcome in children with sickle cell disease. Journal of Anaesthesiology Clinical Pharmacology, 30(1), 20–24. https://doi.org/10.4103/0970-9185.125692
Voepel-Lewis, T., Zanotti, J., Dammeyer, J. A., & Merkel, S. (2010). Reliability and validity of the Face, Legs, Activity, Cry, Consolability behavioral tool in assessing acute pain in critically ill patients. American Journal of Critical Care, 19(1), 55–62. https://doi.org/10.4037/ajcc2010624
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
July 28, 2022
This measure assesses the magnitude of pain experienced by an individual.
Pain intensity can impact social interactions, physical and mental health, and overall quality of life. Pain is a commonly occurring symptom that affects individuals with a variety of diseases and conditions, including sickle cell disease.
PROMIS® Patient-Reported Outcomes Measurement Information System, PROMIS, National Institutes of Health, NIH, pain, pain measurement, pain assessment, sickle cell disease, SCD, type 1 diabetes, asthma, atopic dermatitis
|Protocol ID||Protocol Name|
|860401||Pain Intensity - Adolescent and Adult|
|860402||Pain Intensity - Child|
|860403||Pain Intensity - Toddler|
There are no publications listed for this protocol.