Safety of intravenous administration of tramadol

Exploratory study to evaluate safety and optimal dose and dosage of intravenous administration of tramadol

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031190108

Enrollment

Registered

2019-11-01

Start date

2020-03-03

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

none

Interventions

arm A: single (over 2 minutes) intravenous administration of Tramadol 1.0 mg/kg arm B: single (over 2 minutes) intravenous administration of Tramadol 1.5 mg/kg arm C: single (over 2 minutes) intraveno

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Physical Status Classification of American Society of Anesthesiologist: 1-2 2. 20 to 39 years of age 3. Written informed consent 4. Person who can go to hospital according to study schedule

Exclusion criteria

Exclusion criteria: 1. In the package insert of the study drug, with contraindication - Severe respiratory depression - Consciousness may be disturbed due to head injury, brain lesion, etc. - With a history of hypersensitivity to the components of the drug - Acute poisoning by alcohol, sleep medicine, analgesic, opioid analgesic or psychotropic drug - During administration of monoamine oxidase inhibitor or within 14 days after discontinuation of administration - During administration of nalmefene hydrochloride hydrate or within 7 days after discontinuation of administration - Having epilepsy that is not well managed by treatment 2. Uncontrolled bronchial asthma, hypertension, diabetes 3. Severe liver and kidney disorder and cardiovascular disease 4. Medicine users 5. Person who the research director judged inappropriate as a research subject

Design outcomes

Primary

Measure	Time frame
The incidence of nausea and vomiting due to the difference between dose among 1.0 mg/kg, 1.5 mg/kg and 2.0 mg/kg and administration rate between 2 minutes or over 30 minutes.	—

Secondary

Measure	Time frame
1. Nausea and vomiting onset / cancellation time, degree, treatment, outcome, severity assessment, relationship to study drug 2. Timing of occurrence of other diseases, disappearance time, degree, treatment, outcome, severity assessment, relevance to study drug 3. Change rate of sleepiness (Stanford sleepiness scale) 4. Observer assessment of alertness / sedation scale) 5. Psychomotor function (Digit symbol substitution test) 6. Evaluation of walking ability, dynamic balance and agility (Timed up & go test) 7. Body sway test 8. Bispectral Index (BIS value) 9. Vital (blood pressure, heart rate, respiratory rate, SpO2, EtCO2) 10. Addiction 11. Questionnaire results	—

Measure

Time frame

1. Nausea and vomiting onset / cancellation time, degree, treatment, outcome, severity assessment, relationship to study drug 2. Timing of occurrence of other diseases, disappearance time, degree, treatment, outcome, severity assessment, relevance to study drug 3. Change rate of sleepiness (Stanford sleepiness scale) 4. Observer assessment of alertness / sedation scale) 5. Psychomotor function (Digit symbol substitution test) 6. Evaluation of walking ability, dynamic balance and agility (Timed up & go test) 7. Body sway test 8. Bispectral Index (BIS value) 9. Vital (blood pressure, heart rate, respiratory rate, SpO2, EtCO2) 10. Addiction 11. Questionnaire results

—

Contacts

Public ContactTakashi Goto

Asahi University

takashigoto@dent.asahi-u.ac.jp+81-58-329-1479

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026