PainPhase 3NCT00405444
Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children
A Phase 3 study testing Fentanyl and Sterile water in people with Pain, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether intranasal fentanyl is better than placebo at decreasing pain in children 4-8 years of age during urinary catheterization for a VCUG study. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Pain
- What is being tested?
- Fentanyl and Sterile water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2006to Sep 2008
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4-8 years
- Scheduled VCUG at Sick Kids
- Understand the consent and assent form in English
Who cannot join
- Previous adverse events to fentanyl or any opioid
- History of a chronic respiratory or cardiac illness
- Children with developmental delay
- Children with bilateral nasal congestion.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether intranasal fentanyl is better than placebo at decreasing pain in children 4-8 years of age during urinary catheterization for a VCUG study.
Read the detailed description
Studies have shown that the voiding cystourethrogram (VCUG) can be distressful and painful for children as the child is catheterized during the procedure. Currently no sedation or analgesia is recommended for the procedure. The practice of pediatrics is constantly seeking measures to decrease pain and distress for children. The opioid fentanyl was originally synthesized in the 1950's and 60's as an alternative to morphine and meperidine. The safety and efficacy of intranasal (IN) fentanyl has been previously demonstrated in the setting of a pediatric emergency department.
We are proposing the use of IN fentanyl for analgesia prior to the catheterization for a voiding cystourethrogram (VCUG). If we prove that IN fentanyl is effective in reducing the pain while ensuring patient safety, it could become the analgesic of choice for this procedure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
The dose of fentanyl that each child will receive will be 2 mcg/kg based on the child's weight. The medication will be administered 10 minutes prior to the procedure and will be dropped into the unoccluded nares over 1-2 seconds.
Sterile waterDrug
The dose of sterile water that each child will receive will be 2 mcg/kg based on the child's weight. It will be administered 10 minutes prior to the procedure and will be dropped into the unoccluded nares over 1-2 seconds.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Fentanyl |
| 2 | Placebo comparator | Not described Receives: Drug: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain before and after catheterization for the VCUG.
Measured: Will be measured up until 30 mins after the VCUG procedure.
Secondary outcomes (3)
Heart rate, respiratory rate and oxygen saturation just prior to and after the administration of fentanyl.
Measured: Every 5 minutes until 30 minutes after the VCUG procedure.
Nausea, vomiting, itching, nasal pain/irritation or any other side effects.
Measured: Will be measured up until 30 mins after the VCUG procedure.
Length of stay in diagnostic suite
Measured: Time frame determined by outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Investigators
- Seen Chung, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405444
- Sponsor's protocol ID
- 1000009018
- Status last verified
- Dec 2010
- First submitted
- 28 Nov 2006
- Last updated
- 13 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chung S, Lim R, Goldman RD. Intranasal fentanyl versus placebo for pain in children during catheterization for voiding cystourethrography. Pediatr Radiol. 2010 Jul;40(7):1236-40. doi: 10.1007/s00247-009-1521-1. Epub 2010 Feb 24.
PubMed 20180109
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children
- ClinicalTrials.gov ID
- NCT00405444
- Acronym / sponsor ID
- 1000009018
- Conditions
- Pain
- Keywords
- Pediatrics, Pain, Voiding Cystourethrogram, Catheterization, Fentanyl
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 30 Nov 2006 (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 purpose of this study is to determine whether intranasal fentanyl is better than placebo at decreasing pain in children 4-8 years of age during urinary catheterization for a VCUG study.
Detailed description
Studies have shown that the voiding cystourethrogram (VCUG) can be distressful and painful for children as the child is catheterized during the procedure. Currently no sedation or analgesia is recommended for the procedure. The practice of pediatrics is constantly seeking measures to decrease pain and distress for children. The opioid fentanyl was originally synthesized in the 1950's and 60's as an alternative to morphine and meperidine. The safety and efficacy of intranasal (IN) fentanyl has been previously demonstrated in the setting of a pediatric emergency department.
We are proposing the use of IN fentanyl for analgesia prior to the catheterization for a voiding cystourethrogram (VCUG). If we prove that IN fentanyl is effective in reducing the pain while ensuring patient safety, it could become the analgesic of choice for this procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fentanyl |
| 2 | Placebo comparator | Drug: Sterile water |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 4-8 years
- Scheduled VCUG at Sick Kids
- Understand the consent and assent form in English
Key exclusion criteria (4 listed)
- Previous adverse events to fentanyl or any opioid
- History of a chronic respiratory or cardiac illness
- Children with developmental delay
- Children with bilateral nasal congestion.
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 |
|---|---|---|
| FentanylThe dose of fentanyl that each child will receive will be 2 mcg/kg based on the child's weight. The medication will be administered 10 minutes prior to the procedure and will be dropped into the unoccluded nares over 1-2 seconds. | Drug | 1 |
| Sterile waterThe dose of sterile water that each child will receive will be 2 mcg/kg based on the child's weight. It will be administered 10 minutes prior to the procedure and will be dropped into the unoccluded nares over 1-2 seconds. | Drug | 2 |
Primary outcome
Change in pain before and after catheterization for the VCUG.
Time frame: Will be measured up until 30 mins after the VCUG procedure.
3 secondary outcomes
Heart rate, respiratory rate and oxygen saturation just prior to and after the administration of fentanyl.
Time frame: Every 5 minutes until 30 minutes after the VCUG procedure.
Nausea, vomiting, itching, nasal pain/irritation or any other side effects.
Time frame: Will be measured up until 30 mins after the VCUG procedure.
Length of stay in diagnostic suite
Time frame: Time frame determined by outcome
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 13 Dec 2010.
- Background: PubMed 20180109Chung S, Lim R, Goldman RD. Intranasal fentanyl versus placebo for pain in children during catheterization for voiding cystourethrography. Pediatr Radiol. 2010 Jul;40(7):1236-40. doi: 10.1007/s00247-009-1521-1. Epub 2010 Feb 24.
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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.
Seen Chung, MD principal investigator
The Hospital for Sick Children, Toronto Canada
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 Fentanyl and Sterile water in people with Pain, 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 3 inclusion and 4 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 13 Dec 2010. 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 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?
Change in pain before and after catheterization for the VCUG. (time frame: Will be measured up until 30 mins after the VCUG procedure.). 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 NCT00405444, which also lists 1 linked publication.
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 13 Dec 2010.