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

Phase 4

Withdrawn

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Topic Morphine

• Registration Number: NCT02300194
• Lead Sponsor: Hospital General de Niños Pedro de Elizalde

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).

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 Timeline

• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Study Start: 2014-12
• Status Verified: 2020-04
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Last Update Submitted: 2020-04-20
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Use of topic hydrogel (placebo) for treatment of procedure associated pain
Topic Morphine	Topic Morphine	Use of topic morphine for treatment of procedure associated pain

Primary Outcome Measures

Name	Time	Method
Pain Reduction	4 hours	Proportion of patients with a reduction in pain of least 2 point according to FLACC scale

Trial Locations

Locations (1)

Hospital General de Niños Pedro de Elizalde; 🇦🇷 Ciudad Autonoma de Buenos Aires, Argentina