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

NCT02300194 | Withdrawn Phase 4 DMC

• 1 other identifier: HGNPE-157
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain

Keywords

Pain management

Outcome Measures

Primary Outcomes (1)

• Pain Reduction

  Proportion of patients with a reduction in pain of least 2 point according to FLACC scale

  4 hours

Study Arms (2)

Topic Morphine

ACTIVE COMPARATOR

Use of topic morphine for treatment of procedure associated pain

Drug: Topic Morphine

Placebo

PLACEBO COMPARATOR

Use of topic hydrogel (placebo) for treatment of procedure associated pain

Drug: Placebo

Interventions

Topic Morphine DRUG

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.

Also known as: Morphine gel

Topic Morphine

Placebo DRUG

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.

Also known as: Placebo hidrogel

Placebo

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Hospitalized children aged 1 month to 10 years, who needs a medical procedure over previously injured skin, associated with moderate-severe pain.

You may not qualify if:

• Refusal to participate

Sponsors & Collaborators

• Hospital General de Niños Pedro de Elizalde: lead

Study Sites (1)

Hospital General de Niños Pedro de Elizalde

Buenos Aires, C1270AAN, Argentina

Location

Related 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. No abstract available. Spanish.

  PMID: 19030643 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.

  PMID: 16969231 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.

  PMID: 22658469 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.

  PMID: 22964846 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.

  PMID: 15120772 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.

  PMID: 15210505 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.

  PMID: 18613934 BACKGROUND

Related Links

• World Health Organization 2012

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• María L Yazde-Puleio, MD

  Hospital General de Niños Pedro de Elizalde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: December 1, 2014
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

AR (1)