Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | venepuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| venepuncture | Procedure | venepuncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | in 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Valérie BIRAN, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Armand Trousseau | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14711847 | Result | 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. | |
| 9577286 | Result | Acharya 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| in the 24 hours |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |