Randomized, Double-blind, Placebo, Controlled Cross Over Design Topical Morphine for Analgesia in Pediatric Procedures
Study Details
Study Description
Brief Summary
Introduction:
Opioids, such as morphine, act at receptors in the central nervous system, but many studies have suggested direct action peripherally on opioid receptors in sensory neurons terminals, melanocytes, keratinocytes and fibroblasts. These receptors are stimulated when occurs inflammatory processes.
Hypothesis:
Treatment with topical morphine 0.1% applied 30 minutes before an invasive procedure, decreases pain in children.
Method:
A randomised double-blind parallel study to evaluate the effect of topical application of a 0.1% morphine gel in patients undergo a procedure. 22 patients in each group will be included. Randomly assigned to either the morphine gel or a placebo hydrogel, it will be applied 30 minutes before the procedure and the first day every 4 hours. General basic sedation and systemic analgesia will give for all the patients. Efficacy of treatment will be measured with "Face, Legs, Activity, Cry, Consolability scale" (FLACC scale).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The use of an opioid such as morphine topical gel 30 minutes before a procedure would be effective in reducing pain in children. It has proven effective analgesic with minimal adverse effects, especially in children older than 6 months, and even its use is authorized in young children.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Topic Morphine Use of topic morphine for treatment of procedure associated pain |
Drug: Topic Morphine
Topical application of a 0.1% morphine gel in patients undergo a procedure. It will be applied 30 minutes before the procedure and the first day every 4 hours. General basic sedation and systemic analgesia will give for all the patients. Efficacy of treatment will be measured with FLACC scale.
Other Names:
|
| Placebo Comparator: Placebo Use of topic hydrogel (placebo) for treatment of procedure associated pain |
Drug: Placebo
Topical application of a placebo hydrogel in patients undergo a procedure. It will be applied 30 minutes before the procedure and the first day every 4 hours. General basic sedation and systemic analgesia will give for all the patients. Efficacy of treatment will be measured with FLACC scale.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pain Reduction [4 hours]
Proportion of patients with a reduction in pain of least 2 point according to FLACC scale
Eligibility Criteria
Criteria
Inclusion Criteria:
- Hospitalized children aged 1 month to 10 years, who needs a medical procedure over previously injured skin, associated with moderate-severe pain.
Exclusion Criteria:
- Refusal to participate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital General de Niños Pedro de Elizalde | Ciudad Autonoma de Buenos Aires | Argentina | C1270AAN |
Sponsors and Collaborators
- Hospital General de Niños Pedro de Elizalde
Investigators
- Principal Investigator: María L Yazde-Puleio, MD, Hospital General de Niños Pedro de Elizalde
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Garcia Roig C, Caprotta G, de Castro MF, Germ RM, Lagomarsino E. [Analgesia and sedation in pediatric procedures Part 1: general aspects, sedation scales and pain assessment]. Arch Argent Pediatr. 2008 Oct;106(5):429-34. doi: 10.1590/S0325-00752008000500010. Review. Spanish.
- Heilmann S, Küchler S, Schäfer-Korting M. Morphine metabolism in human skin microsomes. Skin Pharmacol Physiol. 2012;25(6):319-22. doi: 10.1159/000342067. Epub 2012 Sep 8.
- Nielsen BN, Aagaard G, Henneberg SW, Schmiegelow K, Hansen SH, Rømsing J. Topical morphine for oral mucositis in children: dose finding and absorption. J Pain Symptom Manage. 2012 Jul;44(1):117-23. doi: 10.1016/j.jpainsymman.2011.06.029. Epub 2012 Jun 1.
- Nilsson S, Finnström B, Kokinsky E. The FLACC behavioral scale for procedural pain assessment in children aged 5-16 years. Paediatr Anaesth. 2008 Aug;18(8):767-74. doi: 10.1111/j.1460-9592.2008.02655.x.
- Ribeiro MD, Joel SP, Zeppetella G. The bioavailability of morphine applied topically to cutaneous ulcers. J Pain Symptom Manage. 2004 May;27(5):434-9.
- Shavit I, Keidan I, Augarten A. The practice of pediatric procedural sedation and analgesia in the emergency department. Eur J Emerg Med. 2006 Oct;13(5):270-5.
- Watterson G, Howard R, Goldman A. Peripheral opioids in inflammatory pain. Arch Dis Child. 2004 Jul;89(7):679-81.
- HGNPE-157