Primary Tubercular Chorioretinitis Without a Pulmonary Focus: A Case Report.

Ocular tuberculosis (TB) can affect various eye structures and may manifest independently of systemic TB. Typically, it arises from hematogenous dissemination from a primary focus; however, in exceptional instances, it may originate as a primary infection after epithelial injury. Diagnosing TB in an extrapulmonary site presents a significant clinical challenge. We present the case of a 33-year-old Bangladeshi female who presented with a deteriorating loss of vision in her left eye. A thorough neurologic examination and serological tests, the tuberculin skin test, a CT scan of the chest, ocular fundus photography, and optical coherence tomography were performed. Based on the clinical features and the outcome of appropriate tests, a presumptive diagnosis of ocular TB was made and later confirmed after initiating antitubercular therapy, which resulted in a marked improvement in the patient's vision a week later. This case is an illustration of the rare nature and unusual presentation of extrapulmonary TB in the form of tubercular chorioretinitis, diagnosed in a resource-limited setting. Tubercular chorioretinitis, characterized by inflammation of the choroid and retina due to TB infection, presents a diagnostic challenge, especially in resource-limited environments where access to advanced diagnostic tools may be restricted. Therefore, this case highlights the importance of considering TB as a potential cause of ocular manifestations, even in settings where TB prevalence might not be high, and underscores the need for increased awareness and diagnostic capacity for extrapulmonary TB in resource-limited areas. This case exemplifies the infrequent occurrence and atypical manifestation, presenting a learning opportunity for future clinicians.

Right to Occupational Safety: Prevalence of Latent Tuberculosis Infection in Healthcare Workers. A 1-Year Retrospective Survey Carried out at Hospital of Lecce (Italy).

BACKGROUND: Prevention of latent tuberculosis infection (LTBI) in healthcare workers (HCWs) to ensure the "Right to Occupational Safety" is a special challenge globally, as HCWs have a higher risk of acquiring the infection in hospital settings because of frequent close exposure to patients suffering from tuberculosis (TB). METHODS: Aretrospective study was performed with the aim of assessing the prevalence of LTBI related to demographical and occupational risk factors among HCWs employed in a large hospital in Italy. The study involved 1461 HCWs screened for LTBI by Mantoux tuberculin skin test (TST) and then confirmed with Interferon Gamma Release Assay (IGRA) test in case of positivity. Immunosuppressed and BGC-vaccinated workers were tested directly with IGRA. RESULTS: LTBI was diagnosed in 4.1% of the HCWs and the prevalence resulted lower than other studies conducted in low TB incidence countries. The variables significantly linked with higher frequency of the infection were: age ≥40 years (OR = 3.14; 95% CI: 1.13-8.74; p < 0.05), length of service ≥15 years (OR = 4.11; 95% CI: 1.48-11.43; p < 0.05) and not being trained on TB prevention (OR = 3.46; 95% CI: 1.85-6.46; p < 0.05). Not trained HCWs presented a higher risk of LTBI also after adjustment for age and length of service, compared to trained HCWs. CONCLUSIONS: screening of HCWs for LTBI should be always considered in routinely occupational surveillance in order to early diagnose the infection and prevent its progression. Safety policies in hospital settings centered on workers' training on TB prevention is crucial to minimize LTBI occurrence in HCWs.

Tubercular Serpiginous-Like Choroiditis in Patients with Negative TB-Immunoreactivity Tests.

BACKGROUND: Serpiginous-like choroiditis (SLC) denotes ocular tuberculosis (TB), in the presence of positive tuberculin skin test (TST) or interferon gamma release assay (IGRA). METHODS: Retrospective review of SLC patients from a TB-endemic country, with negative TST and IGRA tests, but responsive to anti-TB therapy. RESULTS: Fifteen patients (13 bilateral) with active SLC were included. Eleven (73.3%) patients had received corticosteroids ± immunosuppressive therapy prior to presentation. Chest radiographic abnormalities were found in four (26.7%) patients. We treated all patients with a combination of anti-TB therapy (ATT) and corticosteroids. Paradoxical worsening was noted in nine (60%) patients, complete resolution of lesions in 12 (80%), persistent inflammation (post-ATT) in one, while two were yet to complete ATT. None had recurrence after complete resolution of lesions (median follow-up of 71 weeks [range 15-676 weeks]). CONCLUSIONS: TB-SLC may present with negative TST and IGRA tests but may still have clinical appearance, and treatment response, like test-positive disease.

Interferon-γ release assay and mantoux response in infants with tuberculous meningitis in low and intermediate burden countries.

AIM: Until now, the performance of interferon-γ release assay (IGRA) and Mantoux tests remains unclear in infant tuberculous meningitis (TBM). Therefore, a systematic review is performed to evaluate the sensitivity of IGRA and Mantoux tests for the diagnosis of infant TBM in low and intermediate tuberculosis (TB) burden countries, while following PRISMA. METHODS: Several databases, including PubMed, EBSCO, Embase, Scopus, Web of Science, ClinicalTrials.gov, and Cochrane Central Register of Controlled Trials, were searched. Articles describing the results of IGRA or Mantoux tests among infant TBM were included for analysis. Data, such as age, sex, Mantoux test or IGRA, and cerebrospinal fluid (CSF) microbiological examinations (such as acid-fast bacilli (AFB) smear, TB PCR, and TB culture), were extracted from each study. RESULTS: A total of 31 articles were enrolled for further analysis, including 48 cases. The mean age was 9.4 ± 5.8 months and boys accounted for 57.1% of infants (24/42). Mantoux test was positive in 57.4% (27/47) of tested infants and IGRA was positive in 77.8% (7/9) of infants. In addition, among the infants with confirmed TB, 18 (52.9%, 18/34) of them have positive Mantoux responses and 7 (20.0%, 7/35) have positive IGRA results. CONCLUSIONS: In low or intermediate TB burden countries, the Mantoux test has a poor performance for diagnosing TBM among infants, and IGRAs appear to have a moderate sensitivity for the diagnosis of infant TBM.

Cutaneous tuberculosis. Part II: Complications, diagnostic workup, histopathologic features, and treatment.

Despite the availability of effective treatment regimens for cutaneous tuberculosis, challenges to disease control result from delayed diagnosis, infection with multidrug-resistant mycobacterial strains, and coinfection with HIV. Delayed diagnosis can be mitigated when dermatologists are sensitized to the clinical signs and symptoms of infection and by the incorporation of appropriate diagnostic tests. All cases of cutaneous tuberculosis should be confirmed with histopathology and culture with or without molecular testing. In each case, a thorough evaluation for systemic involvement is necessary. Mycobacteria may not be isolated from cutaneous tuberculosis lesions and therefore, a trial of antituberculosis treatment may be required to confirm the diagnosis. The second article in this 2-part continuing medical education series describes the sequelae, histopathology, and treatment of tuberculosis.

Tubercular DNA PCR of ocular fluids and blood in cases of presumed ocular tuberculosis: a pilot study.

Background: The definitive diagnosing of ocular tuberculosis (TB) is difficult; therefore, there is a need of better understanding of investigating TB DNA in presumed ocular TB patients. Objectives: The aim of this study is to correlate tubercular DNA PCR of aqueous/vitreous and blood in cases of presumed ocular TB. Design: A prospective study. Methods: DNA was extracted from aqueous of cases of choroidal tuberculoma (group 1) and serpiginous choroiditis (group 2) and from vitreous of cases of vasculitis (group 3) and macular hole/retinal detachment (group 4). Gel-based PCR and real-time PCR amplification were performed using IS6110 primer on ocular fluids. The same was also performed on the blood samples of cases in which tubercular DNA was detected in the ocular fluids. Results: Overall, 31 cases were analysed in our study. Tubercular DNA was detected in ocular fluids of seven cases: group 1, two cases (67%); group 2, one case (17%); group 3, four cases (27%); and no case of group 4. Blood samples of six of these seven patients were positive for tubercular DNA. Of these six patients, four had evidence of systemic TB and were on ATT. Two cases had no evidence of active systemic TB, yet PCR was positive from blood and ocular fluids. Conclusion: Tubercular DNA detected from ocular fluids may possibly be due to bystander DNA and may not indicate primary ocular tubercular infection. Thus, caution must be exercised prior to labelling a case of uveitis as being tubercular based on the results of molecular assays on ocular fluids alone. The results of PCR on ocular fluids should be correlated with PCR on blood and systemic findings.

Mantoux test defaulters in rural population attending tertiary care hospital in a tuberculosis endemic area.

Background: Tuberculosis (TB) is one of the main causes of mortality among infectious diseases. The prevalence of tuberculosis is very high in developing countries such as India. Mantoux test is frequently used for the diagnosis of latent or active tuberculosis despite low sensitivity and specificity. However, the Mantoux test is a crucial test in a resource-less setup for the diagnosis of TB. Therefore, the main purpose of this study was to find the dropout rate and dropout reasons in Mantoux testing. Methodology: All suspected TB patients attending out-patient department and further tested for Mantoux test. Results: Of the total 789 Mantoux tests, 459 (58%) were negative, 195 (25%) were positive, and 135 (17%) were dropouts. One of the main reasons for dropout was patients did not give importance to the Mantoux test. Conclusion: Dropout rate in Mantoux testing can be reduced by patient counseling regarding TB and Mantoux test by the doctor.

Genital footprints of extragenital tuberculosis in infertile women: Comparison of various diagnostic modalities.

BACKGROUND: Genital tuberculosis (TB) continues to remain an important cause of infertility in women, especially in developing countries. It is mostly consequent to a primary infection elsewhere in the body. The diagnosis is challenging, considering its paucibacillary nature. Although there are many studies on association of genital tuberculosis with infertility, there is paucity of literature on impact of extragenital tuberculosis on fertility of women through involvement of female reproductive organs. The various diagnostic modalities available have limitations and quest is ongoing for the best diagnostic test. METHOD: This was a prospective observational study conducted at the infertility clinic of a tertiary care health facility where 60 infertile women with either tubal factor or unexplained infertility with or without past history of extragenital tuberculosis were enrolled as study subjects or controls respectively. Mantoux test was performed in all women and diagnostic laparo-hysteroscopy was performed in all women to look for any evidence of uterine and/or tubal damage. The peritoneal fluid was sent for GeneXpert and Liquid culture for mycobacterium tuberculosis. Results of Mantoux test, GeneXpert and liquid culture were compared with the laparohysteroscopic findings. RESULT: Of the thirty infertile women in the study group, 27/30 (90%) had a history of pulmonary tuberculosis and 3/30 (10%) had history of tubercular cervical lymphadenopathy. It was observed that Mantoux test was positive (induration >10 mm) in 27/30 (90%) of women in the study group as compared to only 4/30 (13.3%) controls. Abnormal hysteroscopic findings were documented in 26.6% (8/30) study group women as compared to 6.6% (2/30) women in the control group. Similarly, 60% (18/30) of women in the study group had abnormal laparoscopic findings compared to 33% (10/30) in the control group. Seven out of thirty (23.3%) women were positive for GeneXpert in the study group compared to only 1/30 (3.3%) in the control group. Similarly, liquid culture was positive in 6/30 (20%) of women in the study group as compared to 1/30 (3.3%) in the control group. All the above differences were statistically significant. We observed that the sensitivity of Mantoux test (75.8%) stand alone was higher than the other tests combined (50%). However, specificity and positive predictive value (PPV) increases markedly (up to 100%) to when all the three tests are combined. CONCLUSION: The authors conclude that all women presenting with infertility should be screened for a past history of tuberculosis and actively worked up for genital tuberculosis in case the history is positive. The various available tests (Mantoux test, GeneXpert and liquid culture) have their limitations for the diagnosis of genital tuberculosis. Thus an approach of early resort to laparohysteroscopy in suspected patients is desirable so that definitive management may be instituted timely and promptly.

Diagnostic accuracy of screening algorithms to identify persons with active pulmonary tuberculosis at prison entry: protocol of a systematic review and network meta-analysis.

Prison inmates are a high-risk group for tuberculosis (TB) infection and disease due to the increasing number of vulnerable fringe groups, risk factors (e.g., alcohol and drug addictions), contagious diseases (HIV, hepatitis), and their high-risk behavior. Compared to the general population, TB incidence and prevalence rates are significantly higher among prison inmates. Early identification of potentially infectious pulmonary TB (PTB) and targeted care of sick inmates are essential to effectively control TB within the prison system. The WHO recommends combining active and passive case-finding in prisons. No study has been published comparing the broad spectrum of screening tools using a diagnostic accuracy network meta-analysis (NMA). We aim to identify the most accurate TB case-finding algorithm at prison entry that is feasible in resource-limited prisons of high-burden TB countries and ensures continuous comprehensive TB detection services in such settings. Evidence generated by this NMA can provide important decision support in selecting the most (cost-) effective algorithms for screening methods for resource-limited settings in the short, medium, and long terms.

Exacerbation of generalized plaque psoriasis after tuberculin test.

Koebner phenomenon, also known as isomorphic response, is the appearance of active skin lesions in sites of epidermal injury. This manifestation is characteristic of different dermatological diseases, such as lichen planus, vitiligo and psoriasis. We present the case of a psoriatic patient who experienced Koebner phenomenon after Mantoux test, followed by eruption of generalized plaque psoriasis.

Impact of Latent Tuberculosis on Severity and Outcomes in Admitted COVID-19 Patients.

Background There is limited data on coronavirus disease 2019 (COVID-19) and latent tuberculosis infection (LTBI). Methodology We analyzed data of admitted COVID-19 patients evaluated for LTBI to examine the impact of LTBI on severity, laboratory parameters, and COVID-19 outcome. Prospectively collected data were analyzed for 60 patients who were administered the Mantoux tuberculosis skin test (TST) using five tuberculin units of purified protein derivative. All patients were administered TST irrespective of Bacille Calmette-Guérin (BCG) vaccination status. Comorbidities, clinical features, radiologic involvement, laboratory parameters, and clinical course were analyzed concerning LTBI. Results The mean age was 45.9 (±15.2) years, and 35 (58.3%) patients had non-severe disease. The vast majority (n = 56/60; 93.3%) had been vaccinated with single-dose BCG in infancy or early childhood, as per national immunization guidelines. LTBI was diagnosed in 15 (25%) patients. LTBI prevalence was lower in severe (n = 1/25; 4%) than non-severe (n = 14/35; 40%) COVID-19 (p = 0.01) patients. LTBI patients had lower percentage neutrophil count, higher lymphocyte percentage, higher monocyte count, lower neutrophil-lymphocyte (NL) ratio, lower alanine aminotransferase, lower C-reactive protein, and lesser radiologic involvement compared to those without LTBI (p < 0.05). Similarly, among the mild COVID-19 subgroup, those with LTBI had higher lymphocyte and monocyte counts and lesser radiologic involvement than those without LTBI (p < 0.05). Conclusions LTBI patients appear to have milder disease, higher lymphocyte and monocyte count, higher NL ratio, and lesser radiographic involvement. This observation needs to be studied in larger studies using interferon release assays.

Neonatal Bacille Calmette-Guérin vaccination and tuberculin skin test reactions at 2- and 6-months: Effects on mortality up to 1 year of age.

BACKGROUND: In randomized trials, Bacille Calmette-Guérin (BCG) vaccine has been associated with reduced all-cause mortality. BCG-induced Tuberculin Skin Test (TST) reactions have also been associated with reduced all-cause mortality. We aimed to assess the association between TST responses and subsequent mortality in three birth cohorts and conducted a meta-analysis of existing studies. METHODS: Observational study within three Guinea-Bissau BCG trial birth cohorts (conducted 2002-04, 2009-2013 and 2014-18) that encompassed children who were BCG-vaccinated within 28 days with TSTs performed at 2- (n = 1389) and 6-months (n = 2635) of age. We evaluated TST reaction determinants by binomial regression and assessed the association between TSTs > 1 mm (reactors) vs. ≤ 1 mm (non-reactors) and subsequent mortality risk up to age 12 months in Cox-models providing Mortality Rate Ratios (MRRs). We searched PubMed for studies to calculate meta-estimates of the association between TST reactivity by age 2- and 6-months and all-cause mortality. RESULTS: Large post-vaccination wheal size was associated with 6-month TST positivity and so was receiving BCG-Denmark or BCG-Japan, compared with BCG-Russia. By age 2 months, 22% (302/1389) of infants were TST reactors with a 2-12-month mortality risk of 1.7% (5/302) vs. 3.3% (36/1087) for non-reactors, the corresponding reactor/non-reactor MRR = 0.49 (0.19-1.26). By age 6 months, 44% (1149/2635) of infants were reactors and the 6-12-month mortality risk was 0.4% (4/1149) vs. 0.6% (9/1486) for non-reactors, the MRR = 0.87 (0.27-2.86). The literature search provided 3 studies. The meta-analysis revealed a uniform pattern of reduced mortality associated with TST reactivity, a TST response by 2 months being associated with an MRR of 0.59 (0.39-0.90); for 6-month TST responses the MRR was 0.65 (0.43-1.00). CONCLUSION: Among BCG-vaccinated infants, TST reactions were associated with markedly reduced mortality. Improved vaccination technique and using certain BCG strains could lead to a higher TST reaction prevalence, which would enhance BCG's beneficial non-specific effects.

Significance of Mantoux Test and Its Correlation with Erythrocyte Sedimentation Rate in Pediatric Cleft Lip and Palate Patients: An Institutional Perspective.

AIMS AND OBJECTIVE: This retrospective study evaluates the importance of Mantoux test and Erythrocyte Sedimentation Rate (ESR) levels in pediatric tuberculosis and also signifies the impact of this test in treatment planning and implementation in pediatric cleft lip and palate patients. METHODOLOGY: Retrospective analyses of the records of 2010 pediatric cleft lip and palate patients below 5 years age were performed, and patients with elevated ESR subjected to Mantoux test were identified. The parameters included were age, sex, ESR levels, type of cleft, history of contact with TB & BCG vaccination, Mantoux conversion, chest X-ray findings, number of smear-positive pulmonary tuberculosis. RESULTS: Out of 2010 patients with cleft lip and palate, 180 patients were subjected to Mantoux test due to high ESR levels. Among these, 54 (30%) patients found as Mantoux positive, in which 45 patients were identified as smear-positive pulmonary tuberculosis patients; as a result, surgery was deferred and they underwent antituberculous therapy. Most of the Mantoux-positive cases were found in patients with ESR range of 20-30 mm, i.e., 38 patients (71%), and common age group was 6 months-1 year. The most commonly involved cleft type was: unilateral cleft lip and palate having 36 patients (66.7%). The overall incidence of tuberculosis was 2%. CONCLUSION: Although the correlation of Mantoux test with elevated ESR was not significant in our study, it could be of value as a screening tool along with the Mantoux test, which is sensitive but nonspecific in the diagnosis of active tuberculosis. Together, they could be a valuable screening tool in any community or hospital for diagnosis of the disease.

Prevalence of LTBI among household contacts of sputum positive TB patients receiving DOTS chemotherapy.

OBJECTIVES: 1. To estimate the prevalence of latent tuberculosis infection among household contacts of sputum positive pulmonary tuberculosis patient receiving DOTS chemotherapy. 2. To evaluate the risk factors among household contacts of sputum positive pulmonary tuberculosis patient receiving DOTS chemotherapy. 3. To evaluate the degree of exposure among household contacts of sputum positive pulmonary tuberculosis patient receiving DOTS chemotherapy. METHODS: This study was a cross sectional done among 220 household contacts of age 12 years and above (male and female) of the index sputum positive patients receiving DOTS. Mantoux skin test (Tuberculin Skin Test - TST) was administered by the principal investigator along with TST reading & final diagnosis. Chi-square test was done to find out the association. RESULTS: Out of 220 household contacts tested, 43.6% (96) tested positive for latent TB (induration ≥10mm) with 95% CI ranging from 37% to 50%. The prevalence of latent TB among men and women are 35.6% and 49.2% respectively the difference between which is found to be statistically significant (p = 0.04). Odds Ratio of 5.5 was noted among study subjects who were diabetic (p = 0.018). Household contacts of index patients taking CAT II were at a higher risk than that of CAT I. CONCLUSION: This study clearly shows the high prevalence of latent TB infection among household contacts of sputum positive patients receiving DOTS and so RNTCP should include them in IPT along with under 6 children. The household contacts who spend most time with the index case, who sleep close to them within 5 feet, female household contacts, students, diabetic household contacts are at a significantly higher risk than others.

A case of extra pulmonary tuberculosis misdiagnosed as granulomatosis with polyangitis: Presenting with occipital condylar syndrome.

Sri Lanka is a tuberculosis (TB) prevalent country with an incidence of 8886 cases in 2016 of which 30% were extra pulmonary tuberculosis (EPTB). These figures may be an underestimation, considering the diagnostic challenge of EPTB due to its diverse presentations and difficulty in microbiological confirmation. Here we describe a case of EPTB which was first diagnosed as granulomatosis with polyangitis when he presented with fever, anorexia, wasting, large joint pains, cervical pain, erythema nodosum, high inflammatory markers with strongly positive Mantoux reaction and, necrotizing granulomatous lymphadenitis in the cervical region. Immunosuppression with methotrexate 15 mg weekly and prednisolone 30 mg daily, achieved resolution of symptoms and the inflammatory markers. After about 4 months on tailing off prednisolone, he developed fever, anorexia, wasting and worsening occipital pain which evolved in to occipital condylar syndrome causing hypoglossal nerve palsy. With the aid of serial radiological, histopathological and bacteriological investigations, he was eventually diagnosed to have EPTB involving the left base of the skull with upper mediastinal lymphadenitis. This case highlights the importance to have a high index of suspicion to diagnose EPTB, especially in a country with a high prevalence of TB and to revise the diagnosis with a close follow up to avoid disastrous consequences associated with misdiagnosis.

Presumed Intraocular Tuberculosis Manifesting as Unilateral Iris Granuloma.

Ocular tuberculosis can manifest in a wide variety of clinical presentations. The prevalence is higher in endemic areas as a cause of granulomatous uveitis. While posterior segment manifestations are well known, anterior segment granulomas alone are relatively rare. We report two cases of unilateral iris granulomata in two young patients who presented with decreased vision and redness and were found to have well-circumscribed iris granulomas. Both underwent systemic evaluation and had a negative Mantoux test. Biopsy pathology of the lesions revealed granulomatous inflammation but were negative for PCR, staining, and culture for TB. One patient turned out to have multiple pulmonary lesions. The ocular condition initially worsened with steroid therapy alone and improved and resolved completely after starting a 9 months course of anti-tubercular therapy (ATT).

Comparison of tuberculin skin test and QuantiFERON-TB Gold In-Tube test in Bacillus Calmette-Guerin-vaccinated children.

OBJECTIVES: The aim of this study is to determine the concordance between QuantiFERON-TB Gold In-Tube (QFT-GIT) and tuberculin skin test (TST) in children vaccinated with Bacillus Calmette-Guerin (BCG). METHODS: This cross-sectional study was done at a pediatric tertiary care center in 33 BCG-vaccinated children aged 6 months-15 years suspected of Mycobacterium tuberculosis infection or in contact with a patient with open tuberculosis (TB). All patients were tested for TST with purified protein derivative-S 5 tuberculin units and QFT-GIT assays. Concordance was evaluated between TST and QFT assay by kappa coefficient (k). Agreement between the tests was classified into categories: poor if k < 0.20, fair (k = 0.21-0.40), moderate (k = 0.41-0.60), good (k = 0.61-0.80), and very good (k = 0.81-1.00). RESULTS: Both the TST and QFT assay were positive in 13 and negative in eight children, respectively, resulting in an agreement of 63% (κ = 0.31). Eight children were <4 years of age of which only one patient had a positive TST and QFT-GIT, and TST and QFT-GIT were negative in two patients resulting in an agreement of 37.5% (κ = 0.063). Among children 4 years of age and older, 12 patients had a positive TST and QFT-GIT and 6 patients had a negative TST and QFT-GIT resulting in an agreement of 72% (κ = 0.41). Among 12 children who had been in contact with an adult having open TB, both the TST and QFT-GIT were positive in 6 patients and negative in two patients, respectively, resulting in an agreement of 66% (κ = 0.41). TST specificity was only 29.6% with a positive predictive value of 42.4% as compared to QFT-GIT. Among children <4 years of age, TST specificity was only 28.6% with a positive predictive rate of 16.7%, and among children >4 years of age, TST specificity was 50% with a positive predictive value of 66.7%. In patients with contact with a patient having TB, TST specificity was 33.3%. Considering TST of 15 mm and above as positive, TST specificity increased to 63.2% and a positive predictive value was 56.3%. CONCLUSION: The concordance of TST and QFT-GIT is low in children with previous BCG vaccination and especially in children <4 years of age. QFT-GIT may help to rule out false-positive TST.

Effect of cold vibrator device on pain perception of children aged 6-12 years old undergoing Mantoux Test at Philippine Children's Medical Center out-patient department

@#<p><strong>BACKGROUND:</strong> Painful procedures intensify hospital-related stress and anxiety leading to unpleasant experience that can adversely affect procedure outcomes and health seeking behaviors.</p><p><strong>OBJECTIVE:</strong> To determine the effect of a cold vibrator device on pain perception of children aged 6-12 years old during Mantoux Test at the Out-Patient Department of the Philippine Children's Medical Center.</p><p><strong>METHODOLOGY:</strong> This is a single blinded, randomized control trial where one-hundred four (104) subjects were randomly assigned to experimental (54 subjects) and control group (50 subjects) through fishbowl method. The experimental group received the cold vibrator prior to Mantoux test while the control group received the Mantoux test alone. Pre and post procedural heart rate, respiratory rate and oxygen saturation were obtained. The responses were evaluated using the Wong-Baker Faces Pain Scale.</p><p><strong>RESULTS:</strong> Pain score was higher in the control group. Wilcoxon Rank-Sum Test showed mean rank of 67.5 with aggregated pain rank of 3645.00 compared to experimental group (with cold vibrator) of 36.3 with aggregated pain rank of 1815.00 with a p value 0.0000000046. There was no significant difference between the physiologic parameters (heart rate, respiratory rate, and oxygen saturation) before and after procedure between the two groups.</p><p><strong> CONCLUSION AND RECOMMENDATION:</strong> The use of the cold vibrator was effective in reducing pain perception. It can be used as an adjunct to mitigate pain for needle-related procedures. Demographic data could also be correlated to the pain scores of the subjects. </p>