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

NCT04103801 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2019-09-25

No results posted yet for this study

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.

Conditions

  • Immunisation Anxiety Related Reaction
  • Pain, Acute

Interventions

DIETARY_SUPPLEMENT

Sucrose

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.

Sponsors & Collaborators

  • Jordan University of Science and Technology

    lead OTHER

Principal Investigators

  • Manal K, PhD · Jordan Uinversity of Sceince and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
10 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-14
Primary Completion
2017-12-20
Completion
2018-04-03

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04103801 on ClinicalTrials.gov