PainNCT02512783
Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation
A study testing Lidocaine, Normal Saline and Propofol in people with Pain, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial summary
This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine, Normal Saline and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2014
- 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 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 2 months to 17 years
- patient already scheduled for procedural sedation with propofol
- sedation procedure to be performed by a sedationist from Children's Respiratory and Critical Care Specialists
Who cannot join
- patients who are not receiving deep sedation with propofol
- patients with allergy or other contraindication to lidocaine administration
- patients with central venous catheters as propofol does not burn when given centrally
- patients being premedicated with an analgesic other than nitrous oxide or 1% lidocaine
- patients weighing less than 5 kg to prevent any risk of inadvertent lidocaine overdose.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, 55102
About this study
This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.
Read the detailed description
Propofol is a short-acting, intravenously administered anesthetic. It has become a popular choice for procedural sedation in both children and adults. Despite its many advantages, Propofol is associated with a burning sensation during injection. Propofol pain begins within the first few seconds after administration and often lasts approximately 10-20 seconds until the patient is asleep. Lidocaine is often used in an attempt to reduce Propofol injection pain, but neither its delivery mode nor concentration has been standardized.
The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.
This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the FLACC scale.
- Conditions
- Pain
- Keywords
- Propofol, Lidocaine, Intravenous propofol
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Xylocaine
Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation
Normal SalineDrug
Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation
PropofolDrug
Also called Diprivan, Fresenius Propoven
Intravenous administration of propofol according to standard care to sedate patient.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction. Receives: Drug: Lidocaine; Drug: Propofol |
| Normal Saline | Placebo comparator | Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction. Receives: Drug: Normal Saline; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score
The FLACC scale measures pain in children aged 2m-7y. The scale ranges from 0-10 with 0 being no pain. The total score out of 10 is based on 5 pieces of criteria, and each criteria is scored as either 0, 1, or 2. Scores on individual criteria are summed up to give a total score. Higher values represent a worse outcome of more pain. FLACC scores will be compared pre- and post-propofol induction to assess the change in FLACC score for each arm.
Measured: 1 minute before propofol induction compared to 1 minute following propofol induction
Secondary outcomes (1)
Parental Assessment of Child's Pain on a Visual Analog Scale
Measured: Immediately following propofol injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startMay 2013
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Interim analysis indicated treatment was effective and statistically significant
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 PainStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didima Mon-Sprehe, MD, Principal investigator, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512783
- Sponsor's protocol ID
- 1302-019
- Status last verified
- Jun 2016
- First submitted
- 15 Aug 2013
- Last updated
- 21 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation
- ClinicalTrials.gov ID
- NCT02512783
- Acronym / sponsor ID
- 1302-019
- Conditions
- Pain
- Keywords
- Propofol, Lidocaine, Intravenous propofol
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis indicated treatment was effective and statistically significant
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Posted 17 Jun 2016
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 double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.
Detailed description
Propofol is a short-acting, intravenously administered anesthetic. It has become a popular choice for procedural sedation in both children and adults. Despite its many advantages, Propofol is associated with a burning sensation during injection. Propofol pain begins within the first few seconds after administration and often lasts approximately 10-20 seconds until the patient is asleep. Lidocaine is often used in an attempt to reduce Propofol injection pain, but neither its delivery mode nor concentration has been standardized.
The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.
This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the FLACC scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: Lidocaine, Drug: PropofolAdministration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction. |
| Normal Saline | Placebo comparator | Drug: Normal Saline, Drug: PropofolAdministration of 1ml of pre-treatment normal saline immediately prior to propofol induction. |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age 2 months to 17 years
- patient already scheduled for procedural sedation with propofol
- sedation procedure to be performed by a sedationist from Children's Respiratory and Critical Care Specialists
Key exclusion criteria (5 listed)
- patients who are not receiving deep sedation with propofol
- patients with allergy or other contraindication to lidocaine administration
- patients with central venous catheters as propofol does not burn when given centrally
- patients being premedicated with an analgesic other than nitrous oxide or 1% lidocaine
- patients weighing less than 5 kg to prevent any risk of inadvertent lidocaine overdose.
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 |
|---|---|---|
| LidocaineAlso: XylocaineAdministration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation | Drug | Lidocaine |
| Normal SalineAdministration of 1ml of pre-treatment normal saline 1-minute prior to sedation | Drug | Normal Saline |
| PropofolAlso: Diprivan, Fresenius PropovenIntravenous administration of propofol according to standard care to sedate patient. | Drug | Lidocaine, Normal Saline |
Primary outcome
Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score
Time frame: 1 minute before propofol induction compared to 1 minute following propofol induction
The FLACC scale measures pain in children aged 2m-7y. The scale ranges from 0-10 with 0 being no pain. The total score out of 10 is based on 5 pieces of criteria, and each criteria is scored as either 0, 1, or 2. Scores on individual criteria are summed up to give a total score. Higher values represent a worse outcome of more pain. FLACC scores will be compared pre- and post-propofol induction to assess the change in FLACC score for each arm.
1 secondary outcome
Parental Assessment of Child's Pain on a Visual Analog Scale
Time frame: Immediately following propofol injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- 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.
Didima Mon-Sprehe, MD principal investigator
Children's Hospitals and Clinics of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine, Normal Saline and Propofol in people with Pain, run by Children's Hospitals and Clinics of Minnesota 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 21 Jul 2016. 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 17 Jun 2016). 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?
Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score (time frame: 1 minute before propofol induction compared to 1 minute following propofol induction). 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 21 Jul 2016.