PainPhase 3NCT00519207
Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborns Undergoing Venipuncture
A Phase 3 study testing Lidocaine and 24% Sucrose Solution in people with Pain, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
The objective of this study is to determine the relative efficacy of sucrose, liposomal lidocaine, and sucrose plus liposomal lidocaine, on reducing pain during venipuncture in newborn infants. Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine and 24% Sucrose Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2007to Feb 2009
- 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 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy newborn infants
- ≥ 37 weeks gestational age.
Who cannot join
- neonatal intensive care unit (NICU) admission
- asphyxia, seizures
- major birth defect (heart, brain, genetic syndrome)
- circumcised during study
- receiving analgesia/sedatives.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborn Infants Undergoing Venipuncture: A Randomized Controlled Trial
The objective of this study is to determine the relative efficacy of sucrose, liposomal lidocaine, and sucrose plus liposomal lidocaine, on reducing pain during venipuncture in newborn infants.
Read the detailed description
Despite the fact that modern medical practice is greatly advanced, pain is inflicted on all Canadian newborn infants in the first days and months of life from blood tests, injections and cannulations designed to prevent, diagnose or manage medical conditions. Procedural pain in newborn infants is a significant burden to infants, their parents, healthcare workers, and society at large.
This study proposes a large randomized controlled trial to determine the optimal analgesic regimen for procedural pain using methods that can be easily implemented in clinical practice. We will study liposomal lidocaine cream and sucrose oral liquid, used alone, or together, to manage procedural pain. Liposomal lidocaine is a relatively new anaesthetic formulation ideally suited for young infants due to the established role of lidocaine in neonatal clinical medicine. Sucrose (sugar water) reduces pain responses and is promoted in consensus guidelines developed by pain experts. However, it is perceived by many front-line clinicians to be simply a comforting agent rather than a true analgesic. Studying liposomal lidocaine and sucrose together is important since the combination may prove superior to either agent alone, and may even prevent or abolish pain from clinical procedures.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Maxilene 4
1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.
24% Sucrose SolutionDrug
Also called TootSweet
2ml of 24% sucrose will be administered 2 minutes prior to venipuncture
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | This group will receive lidocaine and sucrose placebo (water). Receives: Drug: Lidocaine |
| 2 | Active comparator | This group will receive lidocaine placebo and sucrose. Receives: Drug: 24% Sucrose Solution |
| 3 | Active comparator | This group will receive lidocaine and sucrose. Receives: Drug: Lidocaine; Drug: 24% Sucrose Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant pain during venipuncture as assessed by facial grimacing response.
Measured: During venipuncture
Secondary outcomes (7)
Visual Analog Scale scores
Measured: During venipuncture
Cry duration
Measured: During venipuncture
Heart rate
Measured: During venipuncture
Number of attempts until procedure completion
Measured: From first needle poke to completion
Endomorphins-1,-2 levels
Measured: Before and 10 minutes after sucrose/sucrose placebo administration
Procedure duration
Measured: From first needle poke to completion
Lidocaine levels
Measured: 5-15 minutes after the study cream is removed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Anna Taddio, PhD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519207
- Sponsor's protocol ID
- 1000010747
- Status last verified
- Jul 2011
- First submitted
- 20 Aug 2007
- Last updated
- 19 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborn Infants Undergoing Venipuncture: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00519207
- Acronym / sponsor ID
- 1000010747
- Conditions
- Pain
- Keywords
- pediatrics, pain, infants, newborn screening, venipuncture, lidocaine, sucrose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 22 Aug 2007 (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.
The objective of this study is to determine the relative efficacy of sucrose, liposomal lidocaine, and sucrose plus liposomal lidocaine, on reducing pain during venipuncture in newborn infants.
Detailed description
Despite the fact that modern medical practice is greatly advanced, pain is inflicted on all Canadian newborn infants in the first days and months of life from blood tests, injections and cannulations designed to prevent, diagnose or manage medical conditions. Procedural pain in newborn infants is a significant burden to infants, their parents, healthcare workers, and society at large.
This study proposes a large randomized controlled trial to determine the optimal analgesic regimen for procedural pain using methods that can be easily implemented in clinical practice. We will study liposomal lidocaine cream and sucrose oral liquid, used alone, or together, to manage procedural pain. Liposomal lidocaine is a relatively new anaesthetic formulation ideally suited for young infants due to the established role of lidocaine in neonatal clinical medicine. Sucrose (sugar water) reduces pain responses and is promoted in consensus guidelines developed by pain experts. However, it is perceived by many front-line clinicians to be simply a comforting agent rather than a true analgesic. Studying liposomal lidocaine and sucrose together is important since the combination may prove superior to either agent alone, and may even prevent or abolish pain from clinical procedures.
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 |
|---|---|---|
| 1 | Active comparator | Drug: LidocaineThis group will receive lidocaine and sucrose placebo (water). |
| 2 | Active comparator | Drug: 24% Sucrose SolutionThis group will receive lidocaine placebo and sucrose. |
| 3 | Active comparator | Drug: Lidocaine, Drug: 24% Sucrose SolutionThis group will receive lidocaine and sucrose. |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy newborn infants
- ≥ 37 weeks gestational age.
Key exclusion criteria (5 listed)
- neonatal intensive care unit (NICU) admission
- asphyxia, seizures
- major birth defect (heart, brain, genetic syndrome)
- circumcised during study
- receiving analgesia/sedatives.
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: Maxilene 41g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing. | Drug | 1, 3 |
| 24% Sucrose SolutionAlso: TootSweet2ml of 24% sucrose will be administered 2 minutes prior to venipuncture | Drug | 2, 3 |
Primary outcome
Infant pain during venipuncture as assessed by facial grimacing response.
Time frame: During venipuncture
7 secondary outcomes
Visual Analog Scale scores
Time frame: During venipuncture
Cry duration
Time frame: During venipuncture
Heart rate
Time frame: During venipuncture
Number of attempts until procedure completion
Time frame: From first needle poke to completion
Endomorphins-1,-2 levels
Time frame: Before and 10 minutes after sucrose/sucrose placebo administration
Procedure duration
Time frame: From first needle poke to completion
Lidocaine levels
Time frame: 5-15 minutes after the study cream is removed
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 Jul 2011.
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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.
Anna Taddio, PhD principal investigator
The Hospital for Sick Children, Toronto Canada
2 sites 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 and 24% Sucrose Solution in people with Pain, run by The Hospital for Sick Children at 2 sites 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 2 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: finished, as of the sponsor's last update on 19 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Infant pain during venipuncture as assessed by facial grimacing response. (time frame: During venipuncture). 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 Jul 2011.