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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Topic Morphine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topic Morphine<br>Use of topic morphine for treatment of procedure associated pain | Drug: Topic Morphine<br>* 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.<br>* Other names: Morphine gel;|
| Placebo Comparator: Placebo<br>Use of topic hydrogel (placebo) for treatment of procedure associated pain | Drug: Placebo<br>* 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.<br>* Other names: Placebo hidrogel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reduction | Proportion of patients with a reduction in pain of least 2 point according to FLACC scale | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain management