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

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103801
• Other study ID #: 127-2015
• Status: Completed
• Phase: N/A
• Start date: July 14, 2017
• Est. completion date: April 3, 2018

Study information

• Verified date: September 2019
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: April 3, 2018
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Months to 18 Months

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Immunisation Anxiety Related Reaction
• Pain, Acute

Intervention

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.

Locations

Country	Name	City	State
Jordan	Maternal and child health centers	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total crying time	The total crying time duration in minute was measured (using the video) from start of injection and to post-immunization Crying	From start of injection and up to 3 minutes after the immunization
Primary	MBPS	Modified Behavioral Pain Scale (MBPS) is a validated procedural uni-dimensional pain measurement tool that used to measure behavioral pain outcomes.	Change MBPS score from the start of injection and up to 3 minutes after immunization
Secondary	Substance P (SP)	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.	Change SP level from the start of injection and up to 3 minutes after immunization