Pain, ChronicPhase 3NCT02983682
Lidocaine Infusions for Chronic Pain in Children
A Phase 3 study testing Lidocaine Infusion in people with Pain, Chronic, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This is a study to evaluate the efficacy and safety of lidocaine in the management of chronic pain in children. All participants will receive lidocaine infusion and severity of pain and degree of chronic-pain related disability will be assessed before and up to 4 weeks after infusion. Adverse events will be recorded. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Lidocaine Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with a chronic pain condition (> 3 months) other conventional medical therapies (anticonvulsants, tricyclics etc), have not been effective.
- American Society of Anesthesiologists class 1 or 2
- Age 8-18 years
- Ability to understand and use the numeric rating scale to rate their pain and to understand and answer other questionnaires
- Negative pregnancy test in participants of child-bearing potential (Females 12 years of age and older, or menarchal if under 12)
Who cannot join
- History of seizures
- Known liver or renal disease
- Patient taking strong CYP1A2 inducers or inhibitors (fluvoxamine, phenytoin, cimetidine, amiodarone) or beta blockers (propranolol, metoprolol, nadolol)
- Allergy or sensitivity to lidocaine or other local anesthetic
- Cardiac conduction anomalies (eg. Heart block, Wolff-Parkinson-White)
- Serum electrolytes (potassium, sodium, magnesium or calcium) outside of reference ranges
Show all 12Show fewer
- Pregnancy
- Withdrawal Criteria
- Patient or parent/guardian request
- Refusal to have intravenous access and serum levels drawn
- Inability to complete pain scores on the questionnaires (paper or electronic) at the first infusion and weekly for 2 weeks and at one month following infusion
- Baseline free carnitine concentration < 26 micromoles/L or total carnitine < 32 micromoles/L (reference values from SickKids Department of Pediatric Laboratory Medicine "Guide to Laboratory Services")
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of the Effectiveness of Lidocaine Infusions for the Management of Chronic Pain in Children
This is a study to evaluate the efficacy and safety of lidocaine in the management of chronic pain in children. All participants will receive lidocaine infusion and severity of pain and degree of chronic-pain related disability will be assessed before and up to 4 weeks after infusion. Adverse events will be recorded.
Read the detailed description
Reports have shown that intravenous lidocaine infusions have been effective in relieving chronic pain that has been resistant to other therapies, with minimal side effects. The investigators would like to determine whether severity of pain and degree of chronic-pain related disability could be reduced with lidocaine infusion in children and to understand whether the dose of lidocaine correlates with blood levels in the same manner as it does in adults. The investigators will recruit 24 patients aged 8-18 with chronic pain that has not been relieved by standard therapies. Each patient will receive a lidocaine infusion over 2 hours. Blood will be drawn for lidocaine concentration before the beginning of the infusion, immediately after and 0.5, 2 and 4 hours after. Severity of pain and degree of disability will be recorded using a questionnaire measuring pain scores, sleep disruption, social disruption, physical abilities and school attendance before the infusion, weekly for 2 weeks and then 4 weeks after. This study will help the investigators better understand the effectiveness and safety of intravenous lidocaine for chronic pain in children.
- Conditions
- Pain, Chronic
- Being tested
- Lidocaine Infusion
- Keywords
- Anesthetics, Local, Lidocaine, Pediatrics, Children, Adolescents
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine InfusionDrug
Also called Preservative Free Lidocaine Hydrochloride
Patients will receive lidocaine infusion of 42 micrograms/kg/minute over tow hours for a total of 5 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Infusion | Experimental | All participants will receive intravenous lidocaine infusion of 42 mcg/kg/minute over 2 hours, for a total of 5 mg/kg. No bolus dose will be given. Receives: Drug: Lidocaine Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Pain scores will be measured using the Numeric Rating Scale
Measured: Change from baseline pain score (7 days prior to infusion) at 14 days after completion of infusion
Secondary outcomes (3)
Analgesic Requirement
Participants will record all analgesics used in a pain diary provided by the investigators.
Measured: Up to seven days prior to lidocaine infusion.
Analgesic Requirement
Participants will record all analgesics used in a pain diary provided by the investigators.
Measured: Up to one month after lidocaine infusion
Adverse Events
Participants will be monitored for adverse events including cardiac arrhythmias, hypotension, hypertension, tachycardia, metallic taste, tinnitus, lightheadedness, nausea, vomiting and headache
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Isaac, The Hospital for Sick Children
- Investigators
- Lisa Isaac, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983682
- Sponsor's protocol ID
- 1000052256
- Status last verified
- Jan 2024
- First submitted
- 15 Apr 2016
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effectiveness of Lidocaine Infusions for the Management of Chronic Pain in Children
- ClinicalTrials.gov ID
- NCT02983682
- Acronym / sponsor ID
- 1000052256
- Conditions
- Pain, Chronic
- Keywords
- Anesthetics, Local, Lidocaine, Pediatrics, Children, Adolescents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the efficacy and safety of lidocaine in the management of chronic pain in children. All participants will receive lidocaine infusion and severity of pain and degree of chronic-pain related disability will be assessed before and up to 4 weeks after infusion. Adverse events will be recorded.
Detailed description
Reports have shown that intravenous lidocaine infusions have been effective in relieving chronic pain that has been resistant to other therapies, with minimal side effects. The investigators would like to determine whether severity of pain and degree of chronic-pain related disability could be reduced with lidocaine infusion in children and to understand whether the dose of lidocaine correlates with blood levels in the same manner as it does in adults. The investigators will recruit 24 patients aged 8-18 with chronic pain that has not been relieved by standard therapies. Each patient will receive a lidocaine infusion over 2 hours. Blood will be drawn for lidocaine concentration before the beginning of the infusion, immediately after and 0.5, 2 and 4 hours after. Severity of pain and degree of disability will be recorded using a questionnaire measuring pain scores, sleep disruption, social disruption, physical abilities and school attendance before the infusion, weekly for 2 weeks and then 4 weeks after. This study will help the investigators better understand the effectiveness and safety of intravenous lidocaine for chronic pain in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Infusion | Experimental | Drug: Lidocaine InfusionAll participants will receive intravenous lidocaine infusion of 42 mcg/kg/minute over 2 hours, for a total of 5 mg/kg. No bolus dose will be given. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed with a chronic pain condition (> 3 months) other conventional medical therapies (anticonvulsants, tricyclics etc), have not been effective.
- American Society of Anesthesiologists class 1 or 2
- Age 8-18 years
- Ability to understand and use the numeric rating scale to rate their pain and to understand and answer other questionnaires
- Negative pregnancy test in participants of child-bearing potential (Females 12 years of age and older, or menarchal if under 12)
Key exclusion criteria (12 listed)
- History of seizures
- Known liver or renal disease
- Patient taking strong CYP1A2 inducers or inhibitors (fluvoxamine, phenytoin, cimetidine, amiodarone) or beta blockers (propranolol, metoprolol, nadolol)
- Allergy or sensitivity to lidocaine or other local anesthetic
- Cardiac conduction anomalies (eg. Heart block, Wolff-Parkinson-White)
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 |
|---|---|---|
| Lidocaine InfusionAlso: Preservative Free Lidocaine HydrochloridePatients will receive lidocaine infusion of 42 micrograms/kg/minute over tow hours for a total of 5 mg/kg. | Drug | Lidocaine Infusion |
Primary outcome
Pain Score
Time frame: Change from baseline pain score (7 days prior to infusion) at 14 days after completion of infusion
Pain scores will be measured using the Numeric Rating Scale
3 secondary outcomes
Analgesic Requirement
Time frame: Up to seven days prior to lidocaine infusion.
Analgesic Requirement
Time frame: Up to one month after lidocaine infusion
Adverse Events
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- 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.
Lisa Isaac, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine Infusion in people with Pain, Chronic, run by The Hospital for Sick Children at 1 site in Canada.
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 5 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 19 Jan 2024. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Score (time frame: Change from baseline pain score (7 days prior to infusion) at 14 days after completion of infusion). 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 19 Jan 2024.