Assessment of the Efficacy of the Transnasal Sphenopalatine Ganglion Block in the Treatment of Ch… (NCT05213065) | Clinical Trial Compass
UnknownNot Applicable
Assessment of the Efficacy of the Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Daily Headache in Children and Adolescents.
Canada120 participantsStarted 2022-02-05
Plain-language summary
Primary Objective The primary objective of the study is to assess whether transnasal sphenopalatine ganglion block using the device TX360 reduces intensity and severity of the Post-Traumatic Headache in adolescents.
Secondary Objectives
The study will also evaluate:
* Quality of life (QoL)
* Intensity of the headache
* Physical function
* Sleep quality
* Role function (measured by PEDMIDAS)
* Adverse events
Who can participate
Age range10 Years – 17 Years
SexALL
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Inclusion criteria
✓. Aged between 10 and 17.5 years old at the start of treatment
✓. Daily Headache, within these categories:
✓. Persistent PTH attributed to Mild traumatic Brain injury to the head
✓. Associated with none of the following:
✓. Associated with one or more of the following symptoms and/or signs:
Exclusion criteria
✕. Previous history of brain imaging showing evidence of intracerebral hemorrhage, subdural or epidural hematomas, or subarachnoid hemorrhage as a consequence of traumatic head injury
✕. Previous history of local anesthetic allergic reaction to bupivacaine
✕. Nasal septal deformity or malformed facial or nasal passages such as cleft lip and palate, choanal atresia, atrophic rhinitis, rhinitis medicamentosa, septal perforation, deviation of the nasal septum, nasal/midface trauma or if he has recently had nasal/sinus surgery
✕. Nasal or facial fracture impeding the use of TX360 device
✕. Serious infection with congestion more than 10 days, and rectal temperature higher than 38°C for more than 1 day9.
✕. Current diagnose of bleeding disorder or recurrent untreated (\> 3/week) nosebleeds for the past 3 months
✕. Severe respiratory distress, as noted by tachypnea or subcostal/intercostal retractions in when breathing