Snake Bites
Conditions
Interventions
The population considered for the present study will correspond to patients treated by the FMT-HVD institution, with botropic accidents. As a phase II A (therapeutic) clinical trial study, the populat
2. Administration of pre-serotherapy using corticosteroids and antihistamines
3. Administration of antivenom 30 minutes after pre-serotherapy.First phase (T1 - first laser application and first clinical evaluation) will take place as follows: - Group 1 considered to be control
E02.594
Sponsors
Universidade do Estado do Amazonas
Fundação de medicina Tropical heitor Vieira Dourado
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients eligible for the study must meet the following characteristics: have less than 24 hours after the accident; being over 18 years old and not having undergone serotherapy for the current botropic accident at another institution.
Exclusion criteria
Exclusion criteria: Those who have an abscess or infection clearly established at the time of admission will be excluded; patient with dry sting; pregnant; Immunocompromised; use anti-inflammatory or antibiotic and have Diabetes mellitus (DM).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: It is expected to find a decrease in myonecrone at the site of the snakebite with the use of laser within 48 hours after admission, being evaluated by creatine phosphokinase (CK).;Outcome found 1: The primary efficacy endpoint of this study was myolysis estimated by the value of creatine phosphokinase (IU/L) within 48 hours after admission. A 53.0% drop in CK was found while the control group increased by 35.0%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: The exploratory efficacy outcomes were: i) pain intensity as measured by a numerical scale and time from admission to reduction of pain intensity by 50%, at 24 and 48 hours after admission; ii) the circumference measurement ratio (circumference of the bitten limb/circumference of the contralateral limb; expressed in %) and time from admission to reduction of circumference measurement ratio by 50%, at 24 and 48 hours after admission; iii) extent of edema in the affected limb by measuring the distance between the distal and proximal points showing swelling (in centimeters) and time from admission to the reduction of the extent of edema by 50%, at 24 and 48 hours after admission; iv) difference between the bite site temperature and that of the contralateral limb (in OC) and time from admission to this reduction by 50%, at 24 and 48 hours after admission; v) need for the use of analgesics in a follow-up of 48 hours; vii) frequency of secondary infections in a follow-up of 48 hours; viii) necrosis in a follow-up of 48 hours, and ix) disability assessment from four to six months after patients’ discharge using the WHODAS 2.0. and assess the feasibility of the proposed intervention.;Outcome found 2: Mean pain intensity 48 hours after admission was significantly lower in the LLLT group (2.9±2.7) in relation to the comparator (5.0±2.4) (P=0.002). The mean circumference measurement ratio was significantly lower in the LLLT group (6.6±6.6; in %) in relation to the comparator (17.1±11.6, in %) (P<0.001). The mean edema extent was significantly lower in the LLLT group (25.8±15.0; in cm) in relation to the comparator (40.1±22.7; in cm) (P=0.001). No difference was observed between the two groups regarding the mean difference between the bite site temperature and the contralateral limb (P=0.110; in OC). No differences were found when comparing WHODAS 2.0 domains between the control and laser groups for each separate domain or the summary scores. | — |
Countries
Brazil
Contacts
Public ContactÉrica Carvalho
Universidade do Estado do Amazonas
Outcome results
None listed