Pain
Conditions
Keywords
Pain management
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.
Interventions
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.
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.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction | 4 hours | Proportion of patients with a reduction in pain of least 2 point according to FLACC scale |
Countries
Argentina