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Assessment of the Efficacy of the Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Daily Headache in Children and Adolescents.

NCT05213065 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-01-28

No results posted yet for this study

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

Conditions

  • Chronic Daily Headache
  • Post-Traumatic Headache

Interventions

OTHER

Sphenopalatine ganglion block with 0.5% bupivacaine

Repetitive SPG blockade using 0.5% bupivacaine delivered with the Tx360® device.

OTHER

Sphenopalatine ganglion block with saline

Repetitive SPG blockade using saline delivered with the Tx360® device.

Sponsors & Collaborators

  • Louise and Alan Edwards Foundation

    collaborator UNKNOWN

  • Pablo Ingelmo

    lead OTHER

Principal Investigators

  • Pablo Ingelmo, MD · Research Institute at the Montreal Childrens Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-05
Primary Completion
2024-02-29
Completion
2024-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05213065 on ClinicalTrials.gov