Protocol - Pain Intensity - Toddler

Add to My Toolkit

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.

Specific Instructions

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.





FaceNo particular expression or smile.Occasional grimace or frown; withdrawn or disinterested; appears sad or worried.Consistent grimace or frown; frequent/constant quivering chin, clenched jaw; distressed-looking face; expression of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.
LegsNormal 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.
ActivityLying 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 sighsArched, rigid or jerking; severe agitation; head banging; shivering (not rigors); breath holding, gasping, or sharp intake of breaths, severe splinting.
CryNo cry/verbalizationMoans or whimpers; occasional complaint; occasional verbal outburst or gruntCrying steadily, screams or sobs, frequent complaints; repeated outbursts, constant grunting.
ConsolabilityContent and relaxedReassured by occasional touching, hugging, or being talked to. DistractibleDifficult 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


Equipment Needs


Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Clinical Examination


Child, Adolescent, Adult


Individuals aged 4–21 years with cognitive impairment

Selection Rationale

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.



Derived Variables


Process and Review

Not Applicable

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

General References

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

Protocol ID


Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX860403030000 Activity N/A
PX860403050000 Consolability N/A
PX860403040000 Cry N/A
PX860403010000 Face N/A
PX860403020000 Legs N/A
Measure Name

Pain Intensity

Release Date

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

Measure Protocols
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.