PainPhase 3NCT00213200
Intravenous and Topical Analgesics for Procedural Pain in Neonates
A Phase 3 study testing morphine, amethocaine in people with Pain and Infant, Newborn, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
This study will test which type of pain medication is best for the management of pain in newborn preterm and full-term infants having a deep intravenous cannula inserted. It will compare the effectiveness of intravenous morphine alone, a local anaesthetic cream (amethocaine) alone, and both medications together. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Pain, Infant, Newborn
- What is being tested?
- morphine, amethocaine
- How many people
- 108 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2003to Jun 2005
- 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 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm and full-term infants in the NICU requiring a percutaneous central venous catheter
- ventilatory support in the form of conventional ventilation, Continuous Positive Air Pressure (CPAP) or High Frequency Oscillation(HFO)
Who cannot join
- seizures
- receiving muscle relaxants
- skin disorders causing disruption of stratum corneum
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: Systemic Analgesia and Local Anaesthesia for Percutaneous Venous Catheter Placement in Preterm Neonates
This study will test which type of pain medication is best for the management of pain in newborn preterm and full-term infants having a deep intravenous cannula inserted. It will compare the effectiveness of intravenous morphine alone, a local anaesthetic cream (amethocaine) alone, and both medications together. It will also determine the safety of both medications.
- Conditions
- Pain, Infant, Newborn
- Being tested
- morphine, amethocaine
- Keywords
- pain, analgesia, morphine, amethocaine, neonate
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morphine, amethocaineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- Facial grimacing, as assessed by brow bulge, at the time of the procedure, compared among groups
Secondary outcomes (5)
heart rate at the time of procedure
oxygen saturation at the time of procedure
local skin reactions at the time of procedure
blood pressure for 24 hours post procedure
ventilatory support for 24 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2003
- Study completionJun 2005
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
- Enrolment
- 108 participants
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Society of Hospital Pharmacists
- Investigators
- Anna Taddio, PhD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213200
- Sponsor's protocol ID
- 0019990251
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 11 Oct 2006
- Results posted
- No
Publications
Taddio A, Lee C, Yip A, Parvez B, McNamara PJ, Shah V. Intravenous morphine and topical tetracaine for treatment of pain in [corrected] neonates undergoing central line placement. JAMA. 2006 Feb 15;295(7):793-800. doi: 10.1001/jama.295.7.793.
PubMed 16478902
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Analgesia and Local Anaesthesia for Percutaneous Venous Catheter Placement in Preterm Neonates
- ClinicalTrials.gov ID
- NCT00213200
- Acronym / sponsor ID
- 0019990251
- Conditions
- Pain, Infant, Newborn
- Keywords
- pain, analgesia, morphine, amethocaine, neonate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Society of Hospital Pharmacists
- Study start
- Jul 2003
- Study completion
- Jun 2005
- First posted
- 21 Sep 2005 (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.
This study will test which type of pain medication is best for the management of pain in newborn preterm and full-term infants having a deep intravenous cannula inserted. It will compare the effectiveness of intravenous morphine alone, a local anaesthetic cream (amethocaine) alone, and both medications together. It will also determine the safety of both medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- preterm and full-term infants in the NICU requiring a percutaneous central venous catheter
- ventilatory support in the form of conventional ventilation, Continuous Positive Air Pressure (CPAP) or High Frequency Oscillation(HFO)
Key exclusion criteria (3 listed)
- seizures
- receiving muscle relaxants
- skin disorders causing disruption of stratum corneum
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 |
|---|---|---|
| morphine, amethocaine | Drug | – |
Primary outcome
- Facial grimacing, as assessed by brow bulge, at the time of the procedure, compared among groups
5 secondary outcomes
heart rate at the time of procedure
oxygen saturation at the time of procedure
local skin reactions at the time of procedure
blood pressure for 24 hours post procedure
ventilatory support for 24 hours post procedure
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 11 Oct 2006.
- Results publication: PubMed 16478902Taddio A, Lee C, Yip A, Parvez B, McNamara PJ, Shah V. Intravenous morphine and topical tetracaine for treatment of pain in [corrected] neonates undergoing central line placement. JAMA. 2006 Feb 15;295(7):793-800. doi: 10.1001/jama.295.7.793.
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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 morphine, amethocaine in people with Pain and Infant, Newborn, 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 3 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 11 Oct 2006. 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?
- Facial grimacing, as assessed by brow bulge, at the time of the procedure, compared among groups. 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 NCT00213200, 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 11 Oct 2006.