Effects of EMLA Cream and Cold Application on Pain in Children During Chest Tube Removal
The Effects of EMLA Cream and Cold Application on Pain, Fear and Vital Signs Before Chest Tube Removal in Children: a Randomized Controlled Trial
This study tests if using EMLA cream or cold packs can help reduce pain and anxiety in children aged 7-18 during chest tube removal after heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Istanbul Medeniyet University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06913855 on ClinicalTrials.gov |
What this trial studies
This study investigates how EMLA cream and cold application can reduce pain, fear, and impact vital signs in children aged 7-18 years undergoing chest tube removal after open heart surgery. The research aims to address the intense pain and anxiety associated with this procedure, which is often a traumatic experience for young patients. By comparing the effects of these two interventions, the study seeks to improve pain management strategies in pediatric care. The findings could lead to better approaches for managing pain and anxiety in children facing similar medical procedures.
Who should consider this trial
Good fit: Ideal candidates are children aged 7-18 years who have two chest tubes placed after open heart surgery and are Turkish literate with stable vital signs.
Not a fit: Patients who have prior experience with chest tube removal, are on analgesics, or have complications such as heart and respiratory failure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve pain management and reduce anxiety for children undergoing chest tube removal.
How similar studies have performed: While there are few studies on pain management during chest tube removal in children, this approach using EMLA cream and cold application is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Having two chest tubes (mediastinal/pleural) placed after open heart surgery * Turkish literate * With stable vital signs * Willing to participate in the research Exclusion Criteria: * Experience with chest tube removal procedure * Using analgesics other than routine procedures before the procedure * Children receiving mechanical ventilation support * Children who have complications in the postoperative period (heart and respiratory failure, repeated surgery, etc.) * Children with a mental disability, perception problem, visual and hearing impairment * Children with communication problems. • Children with cold allergies
Where this trial is running
Istanbul
- Istanbul Medeniyet University — Istanbul, Turkey (Recruiting)
Study contacts
- Study coordinator: Aynur Aytekin Ozdemir, Phd
- Email: aynur.ozdemir@medeniyet.edu.tr
- Phone: +902162804104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.