PainPhase 4NCT01542125
The Effect of Liposomal Lidocaine on Perceived Pain in Children During Percutaneous Interosseous Pin Removal in the Outpatient Setting
A Phase 4 study testing Liposomal Lidocaine in people with Pain, run by University of Alberta.
Trial summary
The removal of smooth, percutaneous pins (Perc Pins), which are used for fracture fixation, occurs once adequate bone healing has taken place. At the Stollery Children's Hospital (SCH), this frequently performed procedure is currently done without anesthetic, making it a painful and uncomfortable experience for the… Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Pain
- What is being tested?
- Liposomal Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 281 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Feb 2011
- Phase
- Phase 4
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 3 and 16 years of age (i.e. up to but not including the 17th birthday) who present to the Pediatric Plaster Room at the SCH for Perc Pin removal were eligible for inclusion in this study.
Who cannot join
- Any patient with Perc Pins that are threaded (not smooth), as these pins require a more difficult removal process, oftentimes in the operating room instead of the orthopedic clinic.
- Infection around the Perc Pins: This is considered a relative contraindication to the use of topical anesthetic as it is usually less effective in this situation.
- Any parents/patients unable to exhibit understanding of the Oucher/VAS -- due to language barriers or developmental delay in the patient (e.g. severe cerebral palsy).
- The presence of an open wound in the vicinity of the pins that could not be excluded from the area to which the topical anesthetic cream is to be applied.
- Present use of analgesic or anxiolytic medications (within 24 hours prior to pin removal)
- Known allergies or adverse reactions to Maxilene
About this study
Official title: The Effect of Liposomal Lidocaine on Perceived Pain in Children During Percutaneous Interosseous Pin Removal in the Outpatient Setting: A Triple Blinded, Randomized Placebo-controlled Clinical Trial
The removal of smooth, percutaneous pins (Perc Pins), which are used for fracture fixation, occurs once adequate bone healing has taken place. At the Stollery Children's Hospital (SCH), this frequently performed procedure is currently done without anesthetic, making it a painful and uncomfortable experience for the child and their caregiver(s). Liposomal Lidocaine is a relatively new effective and "needle-free" topical anesthetic. The investigators were interested in examining its effectiveness in pain reduction in children undergoing Perc Pin removal. Objective: To determine if Liposomal Lidocaine is effective in reducing pain in a pediatric population undergoing Perc Pin removal compared to a placebo. Hypothesis: The investigators hypothesize that Liposomal Lidocaine would significantly reduce pain during Perc Pin removal compared to a placebo. Research Design: This was a triple-blinded, randomized placebo-controlled clinical trial with 281 patients (140 patients each in the Maxilene and 141 in the Placebo groups). Pain measurements, using the Oucher Scale (children) and a 10-cm Visual Analog Scale (parents and caregivers) were collected prior to randomization and immediately after Perc Pin removal. Data was analyzed using a Student's t-test and the Wilcoxon signed ranks test.
- Conditions
- Pain
- Being tested
- Liposomal Lidocaine, Placebo
- Keywords
- Patients aged 3 to 16 years presenting for, removal of smooth percutaneous interosseus pins, after orthopeadic surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal LidocaineDrug
Also called Maxilene
4% Liposomal Lidocaine
PlaceboDrug
Tubes were visually identical to the Liposomal Lidocaine tubes.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Lidocaine group | Experimental | Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing Receives: Drug: Liposomal Lidocaine |
| Placebo Group | Placebo comparator | This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
A horizontal 100 mm anchored Visual Analogue Scale (0 = no pain, 100 = worst possible pain) was used by the adult caregiver and the orthopedic technician to document the pain associated with Perc Pin removal for participant children.
The Oucher Scale was used to assess pain intensity in participant children and included two separate scales. 6 photographs were assigned scores of 0, 20, 40, 60, 80, and 100 (in increasing increments of pain), such that these would be the scores averaged for participants unable to count by number. Children able to count to 100 by ones or tens and who could identify the larger of 2 numbers used the second scale; a vertical numeric one (0-100) that was printed next to the faces.
Measured: Before the application of Liposomal Lidocaine and immediately after Pin Perc removal, approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startSep 2008
- Primary completionFeb 2011
- Study completionFeb 2011
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.
- More trials run by University of AlbertaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sukhdeep Dulai, FRCSC, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542125
- Sponsor's protocol ID
- RES0002737
- Status last verified
- Jun 2016
- First submitted
- 15 Dec 2011
- Last updated
- 12 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Liposomal Lidocaine on Perceived Pain in Children During Percutaneous Interosseous Pin Removal in the Outpatient Setting: A Triple Blinded, Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01542125
- Acronym / sponsor ID
- RES0002737
- Conditions
- Pain
- Keywords
- Patients aged 3 to 16 years presenting for, removal of smooth percutaneous interosseus pins, after orthopeadic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Posted 23 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The removal of smooth, percutaneous pins (Perc Pins), which are used for fracture fixation, occurs once adequate bone healing has taken place. At the Stollery Children's Hospital (SCH), this frequently performed procedure is currently done without anesthetic, making it a painful and uncomfortable experience for the child and their caregiver(s). Liposomal Lidocaine is a relatively new effective and "needle-free" topical anesthetic. The investigators were interested in examining its effectiveness in pain reduction in children undergoing Perc Pin removal. Objective: To determine if Liposomal Lidocaine is effective in reducing pain in a pediatric population undergoing Perc Pin removal compared to a placebo. Hypothesis: The investigators hypothesize that Liposomal Lidocaine would significantly reduce pain during Perc Pin removal compared to a placebo. Research Design: This was a triple-blinded, randomized placebo-controlled clinical trial with 281 patients (140 patients each in the Maxilene and 141 in the Placebo groups). Pain measurements, using the Oucher Scale (children) and a 10-cm Visual Analog Scale (parents and caregivers) were collected prior to randomization and immediately after Perc Pin removal. Data was analyzed using a Student's t-test and the Wilcoxon signed ranks test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Lidocaine group | Experimental | Drug: Liposomal LidocainePatients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing |
| Placebo Group | Placebo comparator | Drug: PlaceboThis group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between 3 and 16 years of age (i.e. up to but not including the 17th birthday) who present to the Pediatric Plaster Room at the SCH for Perc Pin removal were eligible for inclusion in this study.
Key exclusion criteria (6 listed)
- Any patient with Perc Pins that are threaded (not smooth), as these pins require a more difficult removal process, oftentimes in the operating room instead of the orthopedic clinic.
- Infection around the Perc Pins: This is considered a relative contraindication to the use of topical anesthetic as it is usually less effective in this situation.
- Any parents/patients unable to exhibit understanding of the Oucher/VAS -- due to language barriers or developmental delay in the patient (e.g. severe cerebral palsy).
- The presence of an open wound in the vicinity of the pins that could not be excluded from the area to which the topical anesthetic cream is to be applied.
- Present use of analgesic or anxiolytic medications (within 24 hours prior to pin removal)
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 |
|---|---|---|
| Liposomal LidocaineAlso: Maxilene4% Liposomal Lidocaine | Drug | Liposomal Lidocaine group |
| PlaceboTubes were visually identical to the Liposomal Lidocaine tubes. | Drug | Placebo Group |
Primary outcome
Pain
Time frame: Before the application of Liposomal Lidocaine and immediately after Pin Perc removal, approximately 30 minutes
A horizontal 100 mm anchored Visual Analogue Scale (0 = no pain, 100 = worst possible pain) was used by the adult caregiver and the orthopedic technician to document the pain associated with Perc Pin removal for participant children. The Oucher Scale was used to assess pain intensity in participant children and included two separate scales. 6 photographs were assigned scores of 0, 20, 40, 60, 80, and 100 (in increasing increments of pain), such that these would be the scores averaged for participants unable to count by number. Children able to count to 100 by ones or tens and who could identify the larger of 2 numbers used the second scale; a vertical numeric one (0-100) that was printed next to the faces.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sukhdeep Dulai, FRCSC principal investigator
University of Alberta
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal Lidocaine in people with Pain, run by University of Alberta.
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 1 inclusion and 6 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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 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?
Pain (time frame: Before the application of Liposomal Lidocaine and immediately after Pin Perc removal, approximately 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 12 Jul 2016.