Substance P as a Biomarker to Evaluate the Reduction of Multiple Immunization Pain

Jordan University of Science and Technology

Status: Completed

Conditions: Immunisation Anxiety Related Reaction; Pain, Acute

Treatments: Dietary Supplement: Sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT04103801

127-2015

Details and patient eligibility

About

Immunization is one of the most significant preventive health measures in reducing morbidity and mortality caused by infectious diseases. Studies have shown that Sucrose is recommended to reduce pain associated with vaccination in neonates. The main aim of the study was to determine the effectiveness of sucrose in reducing infant's pain outcomes during immunization among 10-24 month-old infants and toddlers.

Enrollment: 132 patients

Sex: All

Ages: 10 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All healthy children who were attending immunization clinic to have their 10-24 month immunization were invited to this study

Exclusion criteria

• Exclusion criteria included children: whose parents choose to breastfeed during immunization, who have received an analgesia in the previous 24 hours including Paracetamol (so as not to affect the response to painful stimuli during immunization), who cannot receive their immunization due to the presence of immunization risk factors as determined by the immunization nurse, who are not able to receive a sugar solution, and whose parents refuse to participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups, including a placebo group

Sucrose group

Experimental group

Description:

This group received the 2 ml of sweet solution (sucrose)

Treatment:

Dietary Supplement: Sucrose

Water group

Placebo Comparator group

Description:

This group received the 2 ml of water

Treatment:

Dietary Supplement: Sucrose