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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02300194
• Date of registration: 20/11/2014
• Prospective Registration: Yes
• Primary sponsor: Hospital General de Niños Pedro de Elizalde
• Public title: Randomized, Double-blind, Placebo, Controlled Cross Over Design Topical Morphine for Analgesia in Pediatric Procedures
• Scientific title: Topical Morphine for Analgesia in Pediatric Procedures. Clinical Trial Randomized, Double-blind, Placebo.
• Date of first enrolment: December 2014
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02300194
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 4

Countries of recruitment

Argentina

Contacts

• Name: María L Yazde-Puleio, MD
• Affiliation: Hospital General de Niños Pedro de Elizalde

Key inclusion & exclusion 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



Age minimum: 1 Month
Age maximum: 10 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Drug: Topic Morphine

Drug: Placebo

Primary Outcome(s)

Pain Reduction [Time Frame: 4 hours]

Secondary ID(s)

HGNPE-157

Source(s) of Monetary Support

Please refer to primary and secondary sponsors