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

Substance P as a Biomarker to Evaluate the Reduction of Multiple Immunization Pain Among Infants and Toddlers: A Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04103801

Enrollment

132

Registered

2019-09-25

Start date

2017-07-14

Completion date

2018-04-03

Last updated

2019-09-25

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

Conditions

Immunisation Anxiety Related Reaction, Pain, Acute

Keywords

Sucrose,, Substance P,, Pain,, Immunization.

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTSucrose

Participants in the intervention group were given 2 ml dose of 50% sucrose solution and participants in the placebo group were given 2 ml dose of sterile water. Both groups were administered slowly over 30 seconds sublingually via needle-less syringe immediately prior to the immunization injections.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

10 Months to 18 Months

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
MBPS	Change MBPS score from the start of injection and up to 3 minutes after immunization	Modified Behavioral Pain Scale (MBPS) is a validated procedural uni-dimensional pain measurement tool that used to measure behavioral pain outcomes.

Secondary

Measure	Time frame	Description
Substance P (SP)	Change SP level from the start of injection and up to 3 minutes after immunization	Change SP level as an indicator of pain and distress level. Saliva was collected from both intervention and placebo groups immediately after treatment in the same manner and similar time schedule. Saliva specimens was immediately cooled in ice and centrifuged at 10,000g at 4 C for 15 min to obtain the supernatant.

Other

Measure	Time frame	Description
Total crying time	From start of injection and up to 3 minutes after the immunization	The total crying time duration in minute was measured (using the video) from start of injection and to post-immunization Crying

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026