The effect of oral melatonin in reduction pain during venipuncture _a double blind clinical trial
Phase 3
Recruiting
- Conditions
- Pain during venipuncture.Other acute postprocedural painG89.18
- Registration Number
- IRCT20220812055665N1
- Lead Sponsor
- Gorgan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 202
Inclusion Criteria
children with 3-6 y reffered to Taleghani Hospital
Parental consent for the child to participate in the study
need to venipuncture for intravenous infusion
Exclusion Criteria
loss of consciousness
acute and life threatening state
any psychological disorder ( autism , ADHD)
any reaction to melatonin
use any sedative or pain relief drug
emergency state
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain score is primary outcome. Timepoint: 30 to 60 min after drug consumption. Method of measurement: FLACC score ( measurement changes of face,legs,activity,cry,consolability).
- Secondary Outcome Measures
Name Time Method Secondary outcome is anxiety. Timepoint: 30-60 min after drug consumption. Method of measurement: observation.;Success in venipuncture. Timepoint: 30-60 min after drug consumption. Method of measurement: observation.;Child cooperation. Timepoint: 30-60 min after drug consumption. Method of measurement: observation.