Melatonin and gabapentin in pain of lumbar puncture in children

Comparison of efficacy of melatonin and gabapentin in reducing of pain and anxiety of lumbar puncture in children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201112032639N7

Enrollment

Registered

2011-12-11

Start date

2011-09-23

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Other disorders of central nervous system. Other disorders of central nervous system

Interventions

Intervention 1: single dose of oral 15 mg/kg of gabapentin is diluted with normal saline. Intervention 2: single dose of oral 0.3mg/kg of melatonin is diluted with normal saline. Intervention 3:

Treatment - Other

Placebo

single dose of oral 15 mg/kg of gabapentin is diluted with normal saline

single dose of oral 0.3mg/kg of melatonin is diluted with normal saline

5 milliliterof oral normal saline

Eligibility

Sex/Gender

All

Age

No minimum to 7 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: children aged one month -7 years; Without systemic diseases and ASA class I or II ; Lumbar puncture are done for the first time; No usage of sedative or hypnotic drugs in recent 48 hours Exclusion Criteria: History of drug allergy; Having neurodevelopmental delay or mental retardation; Loss of consciousness and GCS less than 12

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Succeful lumbar puncture without anxiety and pain. Timepoint: one hour after drug useage during lumbar puncture. Method of measurement: clinical exam.;Obtain of pain score less than 4 in reduction of pain. Timepoint: one hour after drug useage during lumbar puncture. Method of measurement: clinical exam.;Obtain of anxiety score 4 and more in reduction of anxiety of lumbar puncture in children. Timepoint: one hour after drug useage during lumbar puncture. Method of measurement: clinical exam.	—

Measure

Time frame

Succeful lumbar puncture without anxiety and pain. Timepoint: one hour after drug useage during lumbar puncture. Method of measurement: clinical exam.;Obtain of pain score less than 4 in reduction of pain. Timepoint: one hour after drug useage during lumbar puncture. Method of measurement: clinical exam.;Obtain of anxiety score 4 and more in reduction of anxiety of lumbar puncture in children. Timepoint: one hour after drug useage during lumbar puncture. Method of measurement: clinical exam.

—

Secondary

Measure	Time frame
Side effects. Timepoint: one hour after drug usage. Method of measurement: clinical exam.;Mean of time to obtain antianxiety situation. Timepoint: every 15 minutes. Method of measurement: clinical exam.;Mean of time to obtain painless situation. Timepoint: one hour after drug usage during lumbar puncture. Method of measurement: clinical exam.	—

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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