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 range
10 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial focuses specifically on chronic daily headache and post-traumatic headache in children and adolescents, would my child's particular headache type and history make them a reasonable candidate to discuss for this kind of study?
2The main thing this trial is measuring is how many headache days per month a child has — can you walk me through what my child's current headache frequency would need to look like, and whether tracking that at home would be part of our commitment if we explored this?
3A sphenopalatine ganglion block is delivered through the nose rather than by injection — can you explain what that procedure actually feels like for a child, what the known risks are, and how it compares to other treatments we haven't tried yet?
4Since this trial is listed as 'Phase NA' and its recruitment status is unknown, does that mean there are gaps in what's established about how safe or effective this approach is in kids, and should we consider standard headache treatments first before looking into this?
5If we were interested in this trial, how would we find out whether it's still enrolling, and is there a similar study or treatment center you'd recommend we look into closer to home?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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