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Efficacy of lidocaine spray for pain reduction during rabies immunoglobulin infiltration: A double-blind randomized placebo-controlled trial

Efficacy of lidocaine spray for pain reduction during rabiesimmunoglobulin infiltration: A double blind randomized placebo controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241127002
Enrollment
78
Registered
2024-11-27
Start date
2025-04-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Pain control during needle skin penetration and RIG infiltration Pain control, RIG infiltration, lidocaine spray

Interventions

Lidocaine spray (10 mg/o.1 ml/1 spray) total 10 sprays equally to 100mg of lidocaine for pain control during RIG infiltration ,10 sprays of placebo solution
Active Comparator Drug,Placebo Comparator Drug

Sponsors

Navamindradhiraj university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Participants in the study are aged between 18 and 65 years and visit the emergency department at Vajira Hospital with wounds caused by bites or scratches from mammals, qualifying them for rabies post-exposure prophylaxis with immunoglobulin. 2. Participants must be able to communicate in Thai, including reading and writing, and must not have severe communication impairments that prevent them from understanding and providing informed consent through standard procedures, such as severe hearing loss without a hearing aid. 3. Participants must have one of the following healthcare entitlements: 3.1 Social Security benefits at Vajira Hospital 3.2 Universal Health Coverage registered at Vajira Hospital, or participants must have emergency treatment rights 3.3 Government official healthcare benefits with the intention to receive treatment at Vajira Hospital

Exclusion criteria

Exclusion criteria: 1. Participants with a history of allergy to lidocaine, amide-type local anesthetics, alcohol, or preservatives in medications. 2. Body weight less than 30 kilograms. 3. Participants with the following types of wounds: 3.1 Mucosal wounds. 3.2 Wounds requiring sutures, delayed closure, or drain placement. 3.3 Wounds caused by bites or scratches within the past 12 hours (to prevent treatment of potentially infected wounds). 3.4 Wounds larger than 4 centimeters. 3.5 Wounds located on the face, neck, ears, fingers, toes, or genital area. 4. Participants with cardiovascular conditions, such as coronary artery disease, any type of arrhythmia, or those taking anti-arrhythmic drugs in classes 1b and 3, including sodium channel blockers. 5. Participants with a history of seizures (except febrile seizures before age 5). 6. Participants with chronic kidney disease, excluded if diagnosed with stage 4 kidney failure (GFR < 30 mL/min/) or based on unclear renal function results from the past three months. 7. Participants with liver failure (cirrhosis classified as Child-Pugh B or C). 8. Participants with chronic alcohol abuse or dependence, as defined by the SMAST protocol. 9. Participants requiring urgent medical procedures, such as resuscitation. 10. Participants who have taken pain medication within 24 hours before arriving at the emergency department. 11. Participants requiring systemic pain relief (oral, injectable, nasal spray, or transdermal) due to severe pain, rated 7/10 or higher. 12. Participants with wounds caused by factors other than mammalian injuries, such as motorcycle accidents caused by a dog chase. 13. Participants who are unable to provide a pain score.

Design outcomes

Primary

MeasureTime frame
Pain reduction during needle skin penetration and RIG infiltration up to 30 min after RIG infiltration Visual Analog Scale

Secondary

MeasureTime frame
Incidence of adverse events e.g. MP rash, itching, urticaria, severe hypersensitivity reaction, LAST up to 30 min after RIG infiltration Yes/No,Patient satisfaction with the use of spray medication, comparing both the actual drug and the placebo. 30 minutes after finished intervention score 1 - 10

Countries

Thailand

Contacts

Public ContactPichat Areeraksakul

Faculty of Medicine Vajira Hospital

pichatsf@gmail.com0829699887

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Sep 14, 2026