PainPhase 4NCT00484393
Tetracaine Compared to Placebo for Reducing Pain With Palivizumab - A Pilot Study
A Phase 4 study testing tetracaine 4% gel in people with Pain, run by Fraser Health at 1 site in Canada.
Trial summary
This is a small study known as a pilot study. This pilot study is being done to see if a difference in pain from intramuscular palivizumab injection can be detected if tetracaine a topical numbing gel is used compared to no medication (placebo). Read more about this study
- Who is it for?
- Ages 1 month to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- tetracaine 4% gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Apr 2008
- 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 1 month to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants between 1 month and 2 years of age receiving palivizumab at Surrey Memorial Hospital for 2 consecutive intramuscular injections during the 2007/8 season
- Parents need to complete informed consent.
Who cannot join
- Allergy/sensitivity to tetracaine, or ester type anaesthetics.
- Infants who present with fever or illness that prevent administration of palivizumab.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tetracaine (Ametop®) Compared to Placebo for Reducing Pain Associated With Intramuscular Injection of Palivizumab (Synagis®) - A Pilot Study
This is a small study known as a pilot study. This pilot study is being done to see if a difference in pain from intramuscular palivizumab injection can be detected if tetracaine a topical numbing gel is used compared to no medication (placebo). If a difference is found in this pilot study, then a larger study may be done to confirm that there is a difference in pain experience.
Read the detailed description
Objective:
- To determine if tetracaine 4% gel (Ametop ®) reduces the pain of intramuscular palivizumab compared to placebo for pediatric patients between 1 month and 2 years of age.
Rationale:
Premedication with a systemic analgesic has not been shown to be effective in reducing the pain from an acute localized insult. EMLA and tetracaine have been shown to decrease pain associated with immunizations. EMLA requires a 60 minute application, which decreases the usefulness in a busy clinic. Tetracaine has a quicker onset of action and therefore may be more suitable for use in a busy clinic. Efficacy of tetracaine prior to palivizumab has not been reported and therefore it is not known if it can reduce the pain associated with intramuscular palivizumab injection.
Setting:
Respiratory synctial virus (RSV) clinic in the pediatric outpatient ward at Surrey Memorial Hospital.
Procedure:
A notice will be posted in the RSV clinic inviting parents to contact research staff if interested in participating in this study. When a parent contacts staff about the study, a nurse or pharmacist involved in the study will meet with the parent to review eligibility and obtain informed consent.
Once informed consent obtained subject will be randomized by study pharmacist to receive either tetracaine 4% gel (Ametop®) or placebo before administration of the next palivizumab injection (study injection 1); a 4 block randomization design will be used. At the next injection (study injection 2) the subject will receive either tetracaine or placebo, whichever agent they did not receive at study injection 1. The subjects will serve as their own control.
The placebo (Aquatain; Whitehall-Robins, Mississauga, Ontario, Canada) is visually and cosmetically similar to tetracaine 4% gel. One gram of drug or placebo will be dispensed in unit dose 5mL oral syringes, heat sealed to prevent evaporation and stored in a refrigerator for up to one week, after which it will be discarded if unused and redispensed. Tetracaine is commercially available in 1.5g tubes that produce approximately 1g tetracaine.
On the day of immunization and on arrival to the clinic, a clinic nurse who is unaware of the treatment assignment will apply 1g of tetracaine or placebo to the subject's thigh and cover it with a dressing (opcit; Smith and Nephew). They will record the time of the application of the study gel. The clinic nurse will remove the dressing and study gel after 30-45 minutes and record the time of removal. The gel will be wiped from the skin with a paper tissue. A 4-point scale (none, mild, moderate, and severe) will be used to assess local skin reactions after removing study gel. Immediately before the injection the site will be cleaned with an alcohol swab, then the dose (15mg/kg using current weight) of palivizumab will be administered using a ½ - 5/8 inch 23-25 gauge needle. A RSV clinic nurse will inject palivizumab within several minutes of gel removal; clinic nurses will not be aware of the treatment assignment for the subjects.
Study injection 1 and 2 will be video recorded. A mirror will be mounted so the video recorder can capture the subject's reaction both face on and from the mirror image. The videotape will continue until the subject calms down following the injection. The subject can be held by a parent during the injection and provide whatever usual comfort measures they would provide. Following the injection the parent will be asked questions to determine their interpretation of the subject's pain response to the injections and if there any factors that may affect the pain response.
Once both study injections are completed the video will be reviewed and pain assessed for both injections by the same scorer using FLACC pain scale. The scorer will be one pediatric registered nurse who is competent in completing pain analysis for infants. The scorer will be blind as to which dose is tetracaine and which is placebo.
Data Collection:
The data collected will include the FLACC pain scale, parent assessment of patient's pain, factors affecting pain response, as well as identify adverse effects from tetracaine and placebo.
Sample size and statistical Analysis:
The number of subjects with informed consent will determine sample size. Statistical analysis will involve descriptive statistics only.
Ethics:
Confidentiality will always be maintained. No information as to the identify of the child will be placed on the data collection forms. Every child will be assigned a number to facilitate identification by the researchers. Informed consent will be obtained.
Personnel:
A team consisting of nurses, a physician, and a clinical pharmacist from SMH will conduct the study. All personnel are currently involved in the day-to-day management of these children and have the required expertise in carrying out this project.
Timeline:
The study will be submitted for ethical approval by the research ethics board, Fraser Health in April 2007. After approval anticipate patient enrolment to start in November 2007 and complete enrolment by March 2008. A further 4 months will be needed to analyze the data and prepare a manuscript. Expected completion date for the project is July 2008.
Budget:
No additional costs are expected for this study.
- Conditions
- Pain
- Being tested
- tetracaine 4% gel, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tetracaine 4% gelDrug
Also called Ametop
tetracaine applied prior to 1 injection
PlaceboDrug
Also called Aquatain used as placebo to look like tetracaine
placebo applied prior to 1 injection
| Study group | Role | What they receive |
|---|---|---|
| Tetracaine | Experimental | Tetracaine 4% gel 1g applied to injection site Receives: Drug: tetracaine 4% gel |
| Placebo | Placebo comparator | Placebo cream (Aquatain) 1g applied to inejction site Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine.
Parent score 1-10 (1 representing no pain and 10 representing extreme pain) FLACC (Face, Legs, Activity, Cry, Consolability) Score 0-10 (at baseline and post injection) (0 representing no pain and 10 representing extreme pain) Change in FLACC score
Measured: 2 visits, 1 month apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2008
- Study completionApr 2008
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.
- Publications (9)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandi Newby, Fraser Health
- Investigators
- Brandi D Newby, BScPharm, Principal investigator, Surrey Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484393
- Sponsor's protocol ID
- 2007-041
- Status last verified
- May 2015
- First submitted
- 6 Jun 2007
- Last updated
- 19 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Young KD. Pediatric procedural pain. Ann Emerg Med. 2005 Feb;45(2):160-71. doi: 10.1016/j.annemergmed.2004.09.019.
PubMed 15671974Anand KJ, Hickey PR. Pain and its effects in the human neonate and fetus. N Engl J Med. 1987 Nov 19;317(21):1321-9. doi: 10.1056/NEJM198711193172105. No abstract available.
PubMed 3317037Weisman SJ, Bernstein B, Schechter NL. Consequences of inadequate analgesia during painful procedures in children. Arch Pediatr Adolesc Med. 1998 Feb;152(2):147-9. doi: 10.1001/archpedi.152.2.147.
PubMed 9491040Jacobson RM, Swan A, Adegbenro A, Ludington SL, Wollan PC, Poland GA; Vaccine Research Group. Making vaccines more acceptable--methods to prevent and minimize pain and other common adverse events associated with vaccines. Vaccine. 2001 Mar 21;19(17-19):2418-27. doi: 10.1016/s0264-410x(00)00466-7.
PubMed 11257372Meyerhoff AS, Weniger BG, Jacobs RJ. Economic value to parents of reducing the pain and emotional distress of childhood vaccine injections. Pediatr Infect Dis J. 2001 Nov;20(11 Suppl):S57-62. doi: 10.1097/00006454-200111001-00009.
PubMed 11704725O'Brien L, Taddio A, Ipp M, Goldbach M, Koren G. Topical 4% amethocaine gel reduces the pain of subcutaneous measles-mumps-rubella vaccination. Pediatrics. 2004 Dec;114(6):e720-4. doi: 10.1542/peds.2004-0722.
PubMed 15574604Halperin BA, Halperin SA, McGrath P, Smith B, Houston T. Use of lidocaine-prilocaine patch to decrease intramuscular injection pain does not adversely affect the antibody response to diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b conjugate and hepatitis B vaccines in infants from birth to six months of age. Pediatr Infect Dis J. 2002 May;21(5):399-405. doi: 10.1097/00006454-200205000-00010.
PubMed 12150176Zempsky WT, Schechter NL. IMpact-RSV Study Group report. Pediatrics. 1999 Oct;104(4 Pt 1):993-4; author reply 995. No abstract available.
PubMed 10532865Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
PubMed 9220806
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tetracaine (Ametop®) Compared to Placebo for Reducing Pain Associated With Intramuscular Injection of Palivizumab (Synagis®) - A Pilot Study
- ClinicalTrials.gov ID
- NCT00484393
- Acronym / sponsor ID
- 2007-041
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 8 Jun 2007 (estimated)
- Results
- Posted 18 Mar 2015
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 small study known as a pilot study. This pilot study is being done to see if a difference in pain from intramuscular palivizumab injection can be detected if tetracaine a topical numbing gel is used compared to no medication (placebo). If a difference is found in this pilot study, then a larger study may be done to confirm that there is a difference in pain experience.
Detailed description
Objective:
- To determine if tetracaine 4% gel (Ametop ®) reduces the pain of intramuscular palivizumab compared to placebo for pediatric patients between 1 month and 2 years of age.
Rationale:
Premedication with a systemic analgesic has not been shown to be effective in reducing the pain from an acute localized insult. EMLA and tetracaine have been shown to decrease pain associated with immunizations. EMLA requires a 60 minute application, which decreases the usefulness in a busy clinic. Tetracaine has a quicker onset of action and therefore may be more suitable for use in a busy clinic. Efficacy of tetracaine prior to palivizumab has not been reported and therefore it is not known if it can reduce the pain associated with intramuscular palivizumab injection.
Setting:
Respiratory synctial virus (RSV) clinic in the pediatric outpatient ward at Surrey Memorial Hospital.
Procedure:
A notice will be posted in the RSV clinic inviting parents to contact research staff if interested in participating in this study. When a parent contacts staff about the study, a nurse or pharmacist involved in the study will meet with the parent to review eligibility and obtain informed consent.
Once informed consent obtained subject will be randomized by study pharmacist to receive either tetracaine 4% gel (Ametop®) or placebo before administration of the next palivizumab injection (study injection 1); a 4 block randomization design will be used. At the next injection (study injection 2) the subject will receive either tetracaine or placebo, whichever agent they did not receive at study injection 1. The subjects will serve as their own control.
The placebo (Aquatain; Whitehall-Robins, Mississauga, Ontario, Canada) is visually and cosmetically similar to tetracaine 4% gel. One gram of drug or placebo will be dispensed in unit dose 5mL oral syringes, heat sealed to prevent evaporation and stored in a refrigerator for up to one week, after which it will be discarded if unused and redispensed. Tetracaine is commercially available in 1.5g tubes that produce approximately 1g tetracaine.
On the day of immunization and on arrival to the clinic, a clinic nurse who is unaware of the treatment assignment will apply 1g of tetracaine or placebo to the subject's thigh and cover it with a dressing (opcit; Smith and Nephew). They will record the time of the application of the study gel. The clinic nurse will remove the dressing and study gel after 30-45 minutes and record the time of removal. The gel will be wiped from the skin with a paper tissue. A 4-point scale (none, mild, moderate, and severe) will be used to assess local skin reactions after removing study gel. Immediately before the injection the site will be cleaned with an alcohol swab, then the dose (15mg/kg using current weight) of palivizumab will be administered using a ½ - 5/8 inch 23-25 gauge needle. A RSV clinic nurse will inject palivizumab within several minutes of gel removal; clinic nurses will not be aware of the treatment assignment for the subjects.
Study injection 1 and 2 will be video recorded. A mirror will be mounted so the video recorder can capture the subject's reaction both face on and from the mirror image. The videotape will continue until the subject calms down following the injection. The subject can be held by a parent during the injection and provide whatever usual comfort measures they would provide. Following the injection the parent will be asked questions to determine their interpretation of the subject's pain response to the injections and if there any factors that may affect the pain response.
Once both study injections are completed the video will be reviewed and pain assessed for both injections by the same scorer using FLACC pain scale. The scorer will be one pediatric registered nurse who is competent in completing pain analysis for infants. The scorer will be blind as to which dose is tetracaine and which is placebo.
Data Collection:
The data collected will include the FLACC pain scale, parent assessment of patient's pain, factors affecting pain response, as well as identify adverse effects from tetracaine and placebo.
Sample size and statistical Analysis:
The number of subjects with informed consent will determine sample size. Statistical analysis will involve descriptive statistics only.
Ethics:
Confidentiality will always be maintained. No information as to the identify of the child will be placed on the data collection forms. Every child will be assigned a number to facilitate identification by the researchers. Informed consent will be obtained.
Personnel:
A team consisting of nurses, a physician, and a clinical pharmacist from SMH will conduct the study. All personnel are currently involved in the day-to-day management of these children and have the required expertise in carrying out this project.
Timeline:
The study will be submitted for ethical approval by the research ethics board, Fraser Health in April 2007. After approval anticipate patient enrolment to start in November 2007 and complete enrolment by March 2008. A further 4 months will be needed to analyze the data and prepare a manuscript. Expected completion date for the project is July 2008.
Budget:
No additional costs are expected for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetracaine | Experimental | Drug: tetracaine 4% gelTetracaine 4% gel 1g applied to injection site |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo cream (Aquatain) 1g applied to inejction site |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants between 1 month and 2 years of age receiving palivizumab at Surrey Memorial Hospital for 2 consecutive intramuscular injections during the 2007/8 season
- Parents need to complete informed consent.
Key exclusion criteria (2 listed)
- Allergy/sensitivity to tetracaine, or ester type anaesthetics.
- Infants who present with fever or illness that prevent administration of palivizumab.
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 |
|---|---|---|
| tetracaine 4% gelAlso: Ametoptetracaine applied prior to 1 injection | Drug | Tetracaine |
| PlaceboAlso: Aquatain used as placebo to look like tetracaineplacebo applied prior to 1 injection | Drug | Placebo |
Primary outcome
To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine.
Time frame: 2 visits, 1 month apart
Parent score 1-10 (1 representing no pain and 10 representing extreme pain) FLACC (Face, Legs, Activity, Cry, Consolability) Score 0-10 (at baseline and post injection) (0 representing no pain and 10 representing extreme pain) Change in FLACC score
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15671974Young KD. Pediatric procedural pain. Ann Emerg Med. 2005 Feb;45(2):160-71. doi: 10.1016/j.annemergmed.2004.09.019.
- Background: PubMed 3317037Anand KJ, Hickey PR. Pain and its effects in the human neonate and fetus. N Engl J Med. 1987 Nov 19;317(21):1321-9. doi: 10.1056/NEJM198711193172105. No abstract available.
- Background: PubMed 9491040Weisman SJ, Bernstein B, Schechter NL. Consequences of inadequate analgesia during painful procedures in children. Arch Pediatr Adolesc Med. 1998 Feb;152(2):147-9. doi: 10.1001/archpedi.152.2.147.
- Background: PubMed 11257372Jacobson RM, Swan A, Adegbenro A, Ludington SL, Wollan PC, Poland GA; Vaccine Research Group. Making vaccines more acceptable--methods to prevent and minimize pain and other common adverse events associated with vaccines. Vaccine. 2001 Mar 21;19(17-19):2418-27. doi: 10.1016/s0264-410x(00)00466-7.
- Background: PubMed 11704725Meyerhoff AS, Weniger BG, Jacobs RJ. Economic value to parents of reducing the pain and emotional distress of childhood vaccine injections. Pediatr Infect Dis J. 2001 Nov;20(11 Suppl):S57-62. doi: 10.1097/00006454-200111001-00009.
- Background: PubMed 15574604O'Brien L, Taddio A, Ipp M, Goldbach M, Koren G. Topical 4% amethocaine gel reduces the pain of subcutaneous measles-mumps-rubella vaccination. Pediatrics. 2004 Dec;114(6):e720-4. doi: 10.1542/peds.2004-0722.
- Background: PubMed 12150176Halperin BA, Halperin SA, McGrath P, Smith B, Houston T. Use of lidocaine-prilocaine patch to decrease intramuscular injection pain does not adversely affect the antibody response to diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b conjugate and hepatitis B vaccines in infants from birth to six months of age. Pediatr Infect Dis J. 2002 May;21(5):399-405. doi: 10.1097/00006454-200205000-00010.
- Background: PubMed 10532865Zempsky WT, Schechter NL. IMpact-RSV Study Group report. Pediatrics. 1999 Oct;104(4 Pt 1):993-4; author reply 995. No abstract available.
- Background: PubMed 9220806Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
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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.
Brandi D Newby, BScPharm principal investigator
Surrey Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tetracaine 4% gel in people with Pain, run by Fraser Health 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 2 inclusion and 2 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 Jun 2015. 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. 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 18 Mar 2015). 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?
To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine. (time frame: 2 visits, 1 month apart). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00484393, which also lists 9 linked publications.
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 Jun 2015.