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Traditional Chinese Medicine Analgesic Patch for Procedural Pain Alleviation During Pediatric Venipuncture

Investigation into the Preparation of Traditional Chinese Medicine (TCM) Analgesics and the Mechanism of Modulating Pain Nerve Signaling Pathways to Alleviate Pain during Pediatric Venous Puncture

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001838
Enrollment
Unknown
Registered
2025-09-26
Start date
2019-10-01
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

pain

Interventions

EMLA cream patch:Apply the EMLA cream patch to the target blood vessel on the back of the hand 15 minutes before venipentesis
TCM analgesic patch:Apply the TCM analgesic patch to the target blood vessel on the back of the hand 15 minutes before venipentesis
Placebo patch:Apply the Placebo patch to the target blood vessel on the back of the hand 15 minutes before venipentesis

Sponsors

Hubei Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 10 Years

Inclusion criteria

Inclusion criteria: visible dorsal hand veins suitable for cannulation; intact skin sensation without neurological deficits; cognitive ability to comprehend and self-report pain using standardized scales; no documented lidocaine allergy; the age of the child patients spans from 4 to 10 years.

Exclusion criteria

Exclusion criteria: skin abnormalities:dermatological conditions (e.g., eczema, psoriasis, wounds) or infections at the application site; sensory/neurological impairment: peripheral neuropathy, neuropathic pain, or conditions affecting pain perception in hands; cognitive/communicative limitations:inability to understand pain scales due to developmental delay, language barriers, or severe anxiety; pharmacological interference: use of analgesics (e.g., NSAIDs, opioids) within 4 hours prior to procedure, current use of topical steroids or other local agents on hands, history of lidocaine hypersensitivity; medical contraindications: hemodynamic instability (e.g., shock, severe hypotension), coagulopathy or thrombocytopenia; procedural factors:emergency venipuncture requiring immediate cannulation, planned use of ultrasound-guided cannulation.

Design outcomes

Primary

MeasureTime frame
Pain Score;Success Rate of First Venipuncture Attempt;

Secondary

MeasureTime frame
Pulse Rate; Venipuncture-Related Complications;

Countries

China

Contacts

Public ContactYongqun Hu

Hubei Maternal and Child Health Hospital Affiliated to Tongji Hospital of Huazhong University of Science and Technology

905725535@qq.com+86 13871550580

Outcome results

None listed

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