Skip to content

The effect of oral melatonin in reduction pain during venipuncture _a double blind clinical trial

The effect of oral melatonin in reduction pain during venipuncture _a double blind clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220812055665N1
Enrollment
202
Registered
2022-11-28
Start date
2022-11-06
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain during venipuncture. Other acute postprocedural pain

Interventions

Intervention 1: Intervention group: This group includes children to reduce pain and restlessness during venipuncture, melatonin drug will be used for them before venipuncture, and then the success of

Sponsors

Gorgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZohre Akbari jokar

Gorgan University of Medical Sciences

Zohreakbari2351@yahoo.com+98 17 3252 2711

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026