HeadacheNCT00680823
Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache
A study testing Ropivacaine and Normal saline in people with Headache and Migraine, run by Robert Hickey at 1 site in United States.
Trial summary
Objective: To determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- What is being tested?
- Ropivacaine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Chief complaint of headache
- Age 7-17 years
Who cannot join
- Presence of fever
- meningismus
- headache that wakes the child at night
- known organic brain disease, mass, or tumor
- history of stroke
- history of allergy to ropivacaine or other aminoacyl local anesthetics
Show all 12Show fewer
- history of liver disease
- history of impaired cardiac function
- abnormal neurologic signs
- a focal neurologic abnormality on exam that is not a known component of the child's headache syndrome
- cognitive inability to communicate the intensity of pain.
- history of shunt or other intracranial hardware
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Is Paraspinal Intramuscular Ropivacaine Injection an Effective Treatment for Headache in a Pediatric Emergency Department?
Objective: To determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting.
Read the detailed description
Methods: The study will be a double-blind randomized control trial. Patients will be randomly assigned to receive either intramuscular injection of the lower cervical paraspinous muscles with 1 mL of 0.5% ropivacaine on each side, placebo injections with 1 mL normal saline on each side, or no intervention at all. If randomized to an injection, the investigator and the patient will both be blinded as to the nature of the injection.
The location of the child's pain as well as severity will be assessed immediately prior to intervention and every 10 minutes for 30 minutes. If after 30 minutes relief is insufficient for discharge to home, intravenous treatment will be instituted according to current protocol. Pain will be reassessed at the time of ultimate disposition. The scale used to assess severity will vary based on the child's age.
- Being tested
- Ropivacaine, Normal saline
- Keywords
- Headache, Migraine, Ropivacaine
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
Normal salineDrug
1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine Injections | Experimental | Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side. Receives: Drug: Ropivacaine |
| Normal Saline Injections | Placebo comparator | Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side. Receives: Drug: Normal saline |
| Observation | No intervention | Observation for 30 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.
Measured: 30 minutes
Secondary outcomes (2)
Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision
Measured: 3 hours
Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Hickey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Hickey, University of Pittsburgh
- Investigators
- Susan Sieminski, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680823
- Sponsor's protocol ID
- PRO08030283
- Status last verified
- Feb 2018
- First submitted
- 16 May 2008
- Last updated
- 26 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Paraspinal Intramuscular Ropivacaine Injection an Effective Treatment for Headache in a Pediatric Emergency Department?
- ClinicalTrials.gov ID
- NCT00680823
- Acronym / sponsor ID
- PRO08030283
- Keywords
- Headache, Migraine, Ropivacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Robert HickeyUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 May 2008 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting.
Detailed description
Methods: The study will be a double-blind randomized control trial. Patients will be randomly assigned to receive either intramuscular injection of the lower cervical paraspinous muscles with 1 mL of 0.5% ropivacaine on each side, placebo injections with 1 mL normal saline on each side, or no intervention at all. If randomized to an injection, the investigator and the patient will both be blinded as to the nature of the injection.
The location of the child's pain as well as severity will be assessed immediately prior to intervention and every 10 minutes for 30 minutes. If after 30 minutes relief is insufficient for discharge to home, intravenous treatment will be instituted according to current protocol. Pain will be reassessed at the time of ultimate disposition. The scale used to assess severity will vary based on the child's age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine Injections | Experimental | Drug: RopivacaineIntramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side. |
| Normal Saline Injections | Placebo comparator | Drug: Normal salineIntramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side. |
| Observation | No intervention | –Observation for 30 minutes. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Chief complaint of headache
- Age 7-17 years
Key exclusion criteria (12 listed)
- Presence of fever
- meningismus
- headache that wakes the child at night
- known organic brain disease, mass, or tumor
- history of stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1. | Drug | Ropivacaine Injections |
| Normal saline1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1. | Drug | Normal Saline Injections |
Primary outcome
The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.
Time frame: 30 minutes
2 secondary outcomes
Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision
Time frame: 3 hours
Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study
Time frame: 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Sieminski, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine and Normal saline in people with Headache and Migraine, run by Robert Hickey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.