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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02300194
• Other study ID #: HGNPE-157
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: April 2020

Study information

• Verified date: April 2020
• Source: Hospital General de Niños Pedro de Elizalde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Argentina	Hospital General de Niños Pedro de Elizalde	Ciudad Autonoma de Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Niños Pedro de Elizalde

Country where clinical trial is conducted

Argentina, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Reduction	Proportion of patients with a reduction in pain of least 2 point according to FLACC scale	4 hours

External Links

•   World Health Organization 2012