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

NCT05213065 | Unknown

• 1 other identifier: 2021-7715
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of Days of Headache per Month

  Number of Days of Headache per Month

  up to 3 months after last intervention

Secondary Outcomes (7)

• Pain Assessment during the headache

  we will ask after every intervention and up to 3 months after last intervention

• Patient Global Impression of Change scale ( PGIC)

  asked in last visit and 1 month after last intervention again at 3 months after last intervention

• Measure Yourself Medical Outcome Profile ( MYMOP2)

  Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention

• Functional Disability Inventory(FDI)

  Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention

• Pediatric Migraine Disability Assessment (PedMIDAS)

  Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention

Other Outcomes (1)

• Number and Type of Adverse events

  up to 3 months after last intervention

Study Arms (2)

Treatment Arm

EXPERIMENTAL

The participants randomized into this arm will receive the SPG block with 0.5% bupivacaine.

Other: Sphenopalatine ganglion block with 0.5% bupivacaine

Placebo Arm

PLACEBO COMPARATOR

The participants randomized into this arm will receive the SPG block with saline.

Other: Sphenopalatine ganglion block with saline

Interventions

Sphenopalatine ganglion block with 0.5% bupivacaine OTHER

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

Treatment Arm

Sphenopalatine ganglion block with saline OTHER

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

Placebo Arm

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects will be included if they meet all the following 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
• Diagnostic criteria for persistent headache attributed to mild traumatic injury to the head:
• Persistent headache attributed to traumatic injury to the head:
• A. Any headache fulfilling criteria C and D B. Traumatic injury to the head1 has occurred
• C. Headache is reported to have developed within 7 days after one of the following:
• Injury to the head
• Regaining of consciousness following injury to the head
• Discontinuation of medication(s) impairing ability to sense or report headache following injury to the head D. Headache persists for \>3 months after its onset E. Not better accounted for by another ICHD-3 diagnosis Persistent headache attributed to mild traumatic injury to the head A. Headache fulfilling criteria for 5.2 Persistent headache attributed to traumatic injury to the head
• B. Head injury fulfilling both of the following:
• Associated with none of the following:
• Loss of consciousness for \>30 minutes
• Glasgow Coma Scale (GCS) score \<13

You may not qualify if:

• 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
• Angiofibroma, sinus tumors, or granuloma
• Diagnosed or strongly suspected paroxysmal hemicrania or hemicrania continua
• Pregnancy before the completion of the last dose

Sponsors & Collaborators

• Pablo Ingelmo: lead
• Louise and Alan Edwards Foundation: collaborator

Study Sites (1)

McGill University Health Centre (MUHC) - Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (1)

• Kouri M, Somaini M, Cardenas VHG, Niburski K, Vigouroux M, Ingelmo P. Transnasal Sphenopalatine Ganglion Block for the Preventive Treatment of Chronic Daily Headache in Adolescents. Children (Basel). 2021 Jul 18;8(7):606. doi: 10.3390/children8070606.

  PMID: 34356585 BACKGROUND

MeSH Terms

Conditions

Headache Disorders; Post-Traumatic Headache

Interventions

Sphenopalatine Ganglion Block; Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Secondary

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Pablo Ingelmo, MD

  Research Institute at the Montreal Childrens Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Vigouroux

CONTACT

5144124448; marie.Vigouroux@mail.mcgill.ca

Nada A Mohamed, MD

CONTACT

5144124448; nada.mohamed@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Complex Pain Center ,Assistant Professor Pediatric-Anesthesiologist

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: January 28, 2022
• Study Start: February 5, 2022
• Primary Completion: February 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)