drugset / Trial / NCT00530803
The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children
RandomizedParallel-groupTriple-blindSupportive care
Summary
This study compares the efficacy of the Synera patch with Eutectic Mixture of Local Anesthetics (EMLA) as a topical anesthetic for venipuncture in pediatric patients.
Timeline
- Start
- 2007-06
- Primary completion
- 2009-01
- Completion
- 2009-01
Publications
- Background Arts SE, Abu-Saad HH, Champion GD, Crawford MR, Fisher RJ, Juniper KH, Ziegler JB. Age-related response to lidocaine-prilocaine (EMLA) emulsion and effect of music distraction on the pain of intravenous cannulation. Pediatrics. 1994 May;93(5):797-801.
- Background Bishai R, Taddio A, Bar-Oz B, Freedman MH, Koren G. Relative efficacy of amethocaine gel and lidocaine-prilocaine cream for Port-a-Cath puncture in children. Pediatrics. 1999 Sep;104(3):e31. doi: 10.1542/peds.104.3.e31.
- Background Chen E, Zeltzer LK, Craske MG, Katz ER. Children's memories for painful cancer treatment procedures: implications for distress. Child Dev. 2000 Jul-Aug;71(4):933-47. doi: 10.1111/1467-8624.00200.
- Background Cummings EA, Reid GJ, Finley AG, McGrath PJ, Ritchie JA. Prevalence and source of pain in pediatric inpatients. Pain. 1996 Nov;68(1):25-31. doi: 10.1016/S0304-3959(96)03163-6.
- Background Eichenfield LF, Funk A, Fallon-Friedlander S, Cunningham BB. A clinical study to evaluate the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics cream for pain reduction of venipuncture in children. Pediatrics. 2002 Jun;109(6):1093-9. doi: 10.1542/peds.109.6.1093.
- Background Fitzgerald M, Millard C, McIntosh N. Cutaneous hypersensitivity following peripheral tissue damage in newborn infants and its reversal with topical anaesthesia. Pain. 1989 Oct;39(1):31-36. doi: 10.1016/0304-3959(89)90172-3.
- Background Halperin DL, Koren G, Attias D, Pellegrini E, Greenberg ML, Wyss M. Topical skin anesthesia for venous, subcutaneous drug reservoir and lumbar punctures in children. Pediatrics. 1989 Aug;84(2):281-4.
- Background Humphrey GB, Boon CM, van Linden van den Heuvell GF, van de Wiel HB. The occurrence of high levels of acute behavioral distress in children and adolescents undergoing routine venipunctures. Pediatrics. 1992 Jul;90(1 Pt 1):87-91.
- Background Kapelushnik J, Koren G, Solh H, Greenberg M, DeVeber L. Evaluating the efficacy of EMLA in alleviating pain associated with lumbar puncture; comparison of open and double-blinded protocols in children. Pain. 1990 Jul;42(1):31-34. doi: 10.1016/0304-3959(90)91088-Z.
- Background Lawson RA, Smart NG, Gudgeon AC, Morton NS. Evaluation of an amethocaine gel preparation for percutaneous analgesia before venous cannulation in children. Br J Anaesth. 1995 Sep;75(3):282-5. doi: 10.1093/bja/75.3.282.
- Background Ramsook C, Kozinetz CA, Moro-Sutherland D. Efficacy of ethyl chloride as a local anesthetic for venipuncture and intravenous cannula insertion in a pediatric emergency department. Pediatr Emerg Care. 2001 Oct;17(5):341-3. doi: 10.1097/00006565-200110000-00005. No abstract available.
- Background Sethna NF, Verghese ST, Hannallah RS, Solodiuk JC, Zurakowski D, Berde CB. A randomized controlled trial to evaluate S-Caine patch for reducing pain associated with vascular access in children. Anesthesiology. 2005 Feb;102(2):403-8. doi: 10.1097/00000542-200502000-00025.
- Background Wollin SR, Plummer JL, Owen H, Hawkins RM, Materazzo F, Morrison V. Anxiety in children having elective surgery. J Pediatr Nurs. 2004 Apr;19(2):128-32. doi: 10.1016/s0882-5963(03)00146-5.
- Background Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | EMLA Cream | Unknown | 10 g | Topical |
| Comparator | EMLA Cream | Unknown | 20 g | Topical |
| Subject | Synera Patch | Unknown | — | Topical |
Indications
No indication recorded.