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

Primary Purpose

Immunisation Anxiety Related Reaction, Pain, Acute

Status

Completed

Phase

Not Applicable

Locations

Jordan

Study Type

Interventional

Intervention

Sucrose

About this trial

This is an interventional treatment trial for Immunisation Anxiety Related Reaction focused on measuring Sucrose,, Substance P,, Pain,, Immunization.

Eligibility Criteria

10 Months - 18 Months (Child)All SexesAccepts 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.

Sites / Locations

Maternal and child health centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sucrose group

Water group

Arm Description

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

This group received the 2 ml of water

Outcomes

Primary Outcome Measures

MBPS

Modified Behavioral Pain Scale (MBPS) is a validated procedural uni-dimensional pain measurement tool that used to measure behavioral pain outcomes.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04103801

First Posted

October 17, 2018

Last Updated

September 24, 2019

Sponsor

Jordan University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT04103801

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

July 14, 2017 (Actual)

Primary Completion Date

December 20, 2017 (Actual)

Study Completion Date

April 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jordan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immunisation Anxiety Related Reaction, Pain, Acute

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

132 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sucrose group

Arm Type

Experimental

Arm Description

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

Arm Title

Water group

Arm Type

Placebo Comparator

Arm Description

This group received the 2 ml of water

Intervention Type

Dietary Supplement

Intervention Name(s)

Sucrose

Other Intervention Name(s)

Sweet solution

Intervention Description

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.

Primary Outcome Measure Information:

Title

MBPS

Description

Modified Behavioral Pain Scale (MBPS) is a validated procedural uni-dimensional pain measurement tool that used to measure behavioral pain outcomes.

Time Frame

Change MBPS score from the start of injection and up to 3 minutes after immunization

Secondary Outcome Measure Information:

Title

Substance P (SP)

Description

Time Frame

Change SP level from the start of injection and up to 3 minutes after immunization

Other Pre-specified Outcome Measures:

Title

Total crying time

Description

The total crying time duration in minute was measured (using the video) from start of injection and to post-immunization Crying

Time Frame

From start of injection and up to 3 minutes after the immunization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Months

Maximum Age & Unit of Time

18 Months

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manal K, PhD

Organizational Affiliation

Jordan Uinversity of Sceince and Technology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maternal and child health centers

City

Irbid

ZIP/Postal Code

21110

Country

Jordan

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The data is confidential and could not be shared.

Learn more about this trial

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

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