PainPhase 4VIEPNCT00470080
Randomised Trial of Eutectic Mixture of Local Anaesthetics Cream and Oral Sucrose Solution for Venepuncture
A Phase 4 study testing venepuncture in people with Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This randomized bicentric trial will investigate the efficacy of topical EMLA cream with oral sucrose solution compared to oral sucrose solution alone before venepuncture in preterm infants. Read more about this study
- Who is it for?
- Ages 26 to 37 weeks
- Conditions the study is for
- Pain
- What is being tested?
- venepuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2007to Nov 2007
- Phase
- Phase 4
- 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 26 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infants (gestational age between 26 and 37 weeks)
- programmed venepuncture
- APGAR score (M5)≥ 7
- enteral feeding
- written parental consent
Who cannot join
- infant requiring oxygen
- analgesia or sedation or drugs causing methaemoglobinaemia
- congenital porphyria
- G6PD deficit
- multi organ failure
- convulsion
- dermatosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Trial of Eutectic Mixture of Local Anaesthetics Cream and Oral Sucrose Solution for Venepuncture in Preterm Infants
This randomized bicentric trial will investigate the efficacy of topical EMLA cream with oral sucrose solution compared to oral sucrose solution alone before venepuncture in preterm infants.
Read the detailed description
Venepuncture is a painful procedure commonly performed in premature infants. Nonpharmacological intervention (oral sucrose solution) can reduce neonatal pain. EMLA cream is an oil in water emulsion of an eutectic mixture of prilocaine and lignocaine; it is an local anesthetic cream. Very few reports have looked at the efficacy of EMLA in preterm infants.
This randomized bicentric trial will investigate the efficacy of topical EMLA cream with oral sucrose solution compared to oral sucrose solution alone before venepuncture in preterm infants.
- Conditions
- Pain
- Being tested
- venepuncture
- Keywords
- Venepuncture, Pain, Emla cream, Oral sucrose solution, Premature infant, Premature infant admitted to the care baby unit were, included in the study., Programed venepuncture is performed with analgesia.
- Medical subject headings
- Pain, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venepunctureProcedure or surgery
venepuncture
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | venepuncture Receives: Procedure: venepuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of oral sucrose solution and EMLA cream will reduce pain responses in premature infant for venepuncture.A combination of physiological and behavioural responses are used for the measurement of pain in neonates : DAN score and PIPP.
Association of oral sucrose solution and EMLA cream will reduce pain responses in premature infant for venepuncture.A combination of physiological and behavioural responses are used for the measurement of pain in neonates : DAN score and PIPP.
Measured: in 24 hours
Secondary outcomes (1)
Clinical units providing health care in newborns develop written guidelines and protocols for the management of neonatal pain, like venepuncture with the combination of sucrose oral solution and EMLA cream.
Clinical units providing health care in newborns develop written guidelines and protocols for the management of neonatal pain, like venepuncture with the combination of sucrose oral solution and EMLA cream.
Measured: in the 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startJun 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Valérie BIRAN, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470080
- Sponsor's protocol ID
- P060501
- Acronym
- VIEP
- Status last verified
- May 2007
- First submitted
- 4 May 2007
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Acharya AB, Annamali S, Taub NA, Field D. Oral sucrose analgesia for preterm infant venepuncture. Arch Dis Child Fetal Neonatal Ed. 2004 Jan;89(1):F17-8. doi: 10.1136/fn.89.1.f17. No abstract available.
PubMed 14711847Acharya AB, Bustani PC, Phillips JD, Taub NA, Beattie RM. Randomised controlled trial of eutectic mixture of local anaesthetics cream for venepuncture in healthy preterm infants. Arch Dis Child Fetal Neonatal Ed. 1998 Mar;78(2):F138-42. doi: 10.1136/fn.78.2.f138.
PubMed 9577286
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial of Eutectic Mixture of Local Anaesthetics Cream and Oral Sucrose Solution for Venepuncture in Preterm Infants
- ClinicalTrials.gov ID
- NCT00470080
- Acronym / sponsor ID
- VIEP / P060501
- Conditions
- Pain
- Keywords
- Venepuncture, Pain, Emla cream, Oral sucrose solution, Premature infant, Premature infant admitted to the care baby unit were, included in the study., Programed venepuncture is performed with analgesia.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 7 May 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.
This randomized bicentric trial will investigate the efficacy of topical EMLA cream with oral sucrose solution compared to oral sucrose solution alone before venepuncture in preterm infants.
Detailed description
Venepuncture is a painful procedure commonly performed in premature infants. Nonpharmacological intervention (oral sucrose solution) can reduce neonatal pain. EMLA cream is an oil in water emulsion of an eutectic mixture of prilocaine and lignocaine; it is an local anesthetic cream. Very few reports have looked at the efficacy of EMLA in preterm infants.
This randomized bicentric trial will investigate the efficacy of topical EMLA cream with oral sucrose solution compared to oral sucrose solution alone before venepuncture in preterm infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: venepuncturevenepuncture |
Who may qualify
- Ages
- 26 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- preterm infants (gestational age between 26 and 37 weeks)
- programmed venepuncture
- APGAR score (M5)≥ 7
- enteral feeding
- written parental consent
Key exclusion criteria (7 listed)
- infant requiring oxygen
- analgesia or sedation or drugs causing methaemoglobinaemia
- congenital porphyria
- G6PD deficit
- multi organ failure
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 |
|---|---|---|
| venepuncturevenepuncture | Procedure or surgery | 1 |
Primary outcome
Association of oral sucrose solution and EMLA cream will reduce pain responses in premature infant for venepuncture.A combination of physiological and behavioural responses are used for the measurement of pain in neonates : DAN score and PIPP.
Time frame: in 24 hours
Association of oral sucrose solution and EMLA cream will reduce pain responses in premature infant for venepuncture.A combination of physiological and behavioural responses are used for the measurement of pain in neonates : DAN score and PIPP.
1 secondary outcome
Clinical units providing health care in newborns develop written guidelines and protocols for the management of neonatal pain, like venepuncture with the combination of sucrose oral solution and EMLA cream.
Time frame: in the 24 hours
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 4 May 2011.
- Results publication: PubMed 14711847Acharya AB, Annamali S, Taub NA, Field D. Oral sucrose analgesia for preterm infant venepuncture. Arch Dis Child Fetal Neonatal Ed. 2004 Jan;89(1):F17-8. doi: 10.1136/fn.89.1.f17. No abstract available.
- Results publication: PubMed 9577286Acharya AB, Bustani PC, Phillips JD, Taub NA, Beattie RM. Randomised controlled trial of eutectic mixture of local anaesthetics cream for venepuncture in healthy preterm infants. Arch Dis Child Fetal Neonatal Ed. 1998 Mar;78(2):F138-42. doi: 10.1136/fn.78.2.f138.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Valérie BIRAN, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 venepuncture in people with Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 7 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 4 May 2011. 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 France. 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 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?
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?
Association of oral sucrose solution and EMLA cream will reduce pain responses in premature infant for venepuncture.A combination of physiological and behavioural responses are used for the measurement of pain in neonates : DAN score and PIPP. (time frame: in 24 hours). 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 NCT00470080, which also lists 2 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 4 May 2011.