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Comparing Buzzy Device With Emla Cream in Needle Related Pain

NCT05354739 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2022-04-29

No results posted yet for this study

Summary

This randomized controlled study will enroll the eligible patients to either the Buzzy device arm or to the EMLA cream arm as a standard therapy. This will be done with concealment; however, blinding will not be practical. Will include 300 participants with 150 in each arm in Al Saad pediatric emergency. The research nurse will use a known valid and reliable measurements scales for the pain and anxiety. The data will be recorded with timing in a prepared form, The SPSS 22.0 and Epi-info soft wares and appropriate statistical tests will be used and will consider P value of \<0.05 is statistically significant. The investigators are anticipating a Buzzy device effectiveness to be not less than the EMLA cream but the rapidity of effectiveness in buzzy device of around one minute compared to 30-45 minutes of EMLA cream will be an important outcome in a busy emergency department.

Conditions

  • Procedural Pain

Interventions

DEVICE

The vibration cold device (BUZZY)

If the patient fulfils the inclusions criteria, the research nurse will obtain informed consent from a parent or legal guardian and assent form if the child is 7years or older. She will assess the ability of the child to use the Faces Pain Scale-Revised (FPS-R), as a pain assessment instrument used by the child. It is a six cartoon faces showing a normal facial expression if no pain, progressing into the facial expression with very severe pain. FPS-R is graded from zero to ten; the child will be asked to quantify the pain by: no hurt, hurt, or very much hurt. This scale is widely used not only in research but also in a routine bases in ours and other units by the nursing staff and are familiar with it. The research nurse is one of the nurses used the same scale during the routine work and will be trained further to ensure consistency, she will document the findings prior, during and after the procedure. This instrument was reliable, valid, and standardized

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Nasser Haidar · Hamad Medical Corporation

Eligibility

Min Age
2 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-02
Primary Completion
2021-09-29
Completion
2021-09-29

Countries

  • Qatar

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 NCT05354739 on ClinicalTrials.gov