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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
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Pain Drug: Topic Morphine Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Placebo
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




Primary Outcome Measures :
  1. Pain Reduction [ Time Frame: 4 hours ]
    Proportion of patients with a reduction in pain of least 2 point according to FLACC scale



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Ages Eligible for Study:   1 Month to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Fernando Ferrero 5443632100 ext 1014 fferrero@intramed.net

Locations
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Argentina
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    fferrero@intramed.net   
Principal Investigator: María L Yazde-Puleio, MD         
Sponsors and Collaborators
Hospital General de Niños Pedro de Elizalde
Investigators
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Principal Investigator: María L Yazde-Puleio, MD Hospital General de Niños Pedro de Elizalde

Publications:
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Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT02300194     History of Changes
Other Study ID Numbers: HGNPE-157
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

Keywords provided by Hospital General de Niños Pedro de Elizalde:
Pain management

Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents