Randomized, Double-blind, Placebo, Controlled Cross Over Design Topical Morphine for Analgesia in Pediatric Procedures

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).

Timeline

Start

2014-12

Primary completion

2020-04

Completion

2020-04

Outcome

Outcome not reported

Stopped: “Withdrawn by investigators”

Publications

• Background 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. No abstract available. Spanish.
• Background 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. doi: 10.1097/00063110-200610000-00005.
• Background Nielsen BN, Aagaard G, Henneberg SW, Schmiegelow K, Hansen SH, Romsing 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.
• Background Heilmann S, Kuchler S, Schafer-Korting M. Morphine metabolism in human skin microsomes. Skin Pharmacol Physiol. 2012;25(6):319-22. doi: 10.1159/000342067. Epub 2012 Sep 8.
• Background 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. doi: 10.1016/j.jpainsymman.2003.09.011.
• Background Watterson G, Howard R, Goldman A. Peripheral opioids in inflammatory pain. Arch Dis Child. 2004 Jul;89(7):679-81. doi: 10.1136/adc.2003.032003.
• Background Nilsson S, Finnstrom 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.

Drugs

Indications

No indication recorded.