Randomized, Double-blind, Placebo, Controlled Cross Over Design Topical Morphine for Analgesia in Pediatric Procedures
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|ClinicalTrials.gov Identifier: NCT02300194|
Recruitment Status : Recruiting
First Posted : November 24, 2014
Last Update Posted : September 11, 2018
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.
Treatment with topical morphine 0.1% applied 30 minutes before an invasive procedure, decreases pain in children.
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).
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Topic Morphine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Topical Morphine for Analgesia in Pediatric Procedures. Clinical Trial Randomized, Double-blind, Placebo.|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Topic Morphine
Use of topic morphine for treatment of procedure associated pain
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.
Other Name: Morphine gel
Placebo Comparator: Placebo
Use of topic hydrogel (placebo) for treatment of procedure associated pain
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.
Other Name: Placebo hidrogel
- Pain Reduction [ Time Frame: 4 hours ]Proportion of patients with a reduction in pain of least 2 point according to FLACC scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300194
|Contact: Fernando Ferrero||5443632100 ext firstname.lastname@example.org|
|Hospital General de Niños Pedro de Elizalde||Recruiting|
|Ciudad Autonoma de Buenos Aires, Argentina, C1270AAN|
|Contact: Fernando Ferrero, MD, PhD + 54 11 43632100 ext 1014 email@example.com|
|Principal Investigator: María L Yazde-Puleio, MD|
|Principal Investigator:||María L Yazde-Puleio, MD||Hospital General de Niños Pedro de Elizalde|