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

Condition(s) targeted: Pain

Intervention: Topic Morphine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hospital General de Niños Pedro de Elizalde

Official(s) and/or principal investigator(s):
María L Yazde-Puleio, MD, Principal Investigator, Affiliation: Hospital General de Niños Pedro de Elizalde

Overall contact:
Fernando Ferrero, Phone: 5443632100, Ext: 1014, Email: fferrero@intramed.net

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).

Official title: Topical Morphine for Analgesia in Pediatric Procedures. Clinical Trial Randomized, Double-blind, Placebo.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Pain Reduction

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.

Minimum age: 1 Month. Maximum age: 10 Years. Gender(s): Both.

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

Fernando Ferrero, Phone: 5443632100, Ext: 1014, Email: fferrero@intramed.net

Hospital General de Niños Pedro de Elizalde, Ciudad Autonoma de Buenos Aires C1270AAN, Argentina; Recruiting
Fernando Ferrero, MD, PhD, Phone: + 54 11 43632100, Ext: 1014, Email: fferrero@intramed.net
María L Yazde-Puleio, MD, Principal Investigator

World Health Organization 2012

Related 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.

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.

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.

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.

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.

Watterson G, Howard R, Goldman A. Peripheral opioids in inflammatory pain. Arch Dis Child. 2004 Jul;89(7):679-81.

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.

Starting date: December 2014
Last updated: August 19, 2015