Chest Tube RemovalNCT06913855
The Effects of EMLA Cream and Cold Application on Pain, Fear and Vital Signs Before Chest Tube Removal in Children
A study testing EMLA Cream and Cold application in people with Chest Tube Removal and Children, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study is being conducted to determine the effect of EMLA cream and cold application on pain, fear and vital signs before chest tube removal in children aged 7-18 years. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Chest Tube Removal, Children, Pain Management
- What is being tested?
- EMLA Cream and Cold application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2025to 5 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Having two chest tubes (mediastinal/pleural) placed after open heart surgery
- Turkish literate
- With stable vital signs
- Willing to participate in the research
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 is being conducted to determine the effect of EMLA cream and cold application on pain, fear and vital signs before chest tube removal in children aged 7-18 years.
Read the detailed description
A chest tube is a device used to drain air or fluid from the pleural cavity under sterile conditions by inserting a thin or thick tube. Chest tubes adhere to the endothelium of the chest cavity after insertion and while in place. For this reason, the pulling force applied when they are removed breaks these adhesions and causes intense, localised and transient acute pain. Chest tube removal pain, defined as one of the patient's worst life experiences related to the surgical procedure, is an iatrogenic pain caused by an invasive procedure. Therefore, chest tube removal is a painful, anxious and frightening experience for the patient. There are few studies of pharmacological and non-pharmacological methods of pain control during chest tube removal in children. However, the management of pain associated with surgical procedures in childhood is very important for the management of pain, anxiety and fear that children will experience with future medical procedures.
- Conditions
- Chest Tube Removal, Children, Pain Management
- Being tested
- EMLA Cream, Cold application
- Keywords
- Chest tube removal, Children, Pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLA CreamDrug
EMLA cream is applied once, 3 hours before the tube is removed. EMLA cream will be applied by the researcher in a thin layer to an area of 7-10 cm2, with the chest tube entrance to the skin remaining in the center. It will be covered with a Tegaderm transparent film dressing.
Cold applicationProcedure or surgery
Cold application will be made with an ice cube pack immediately before the chest tube removal procedure. Cold application will be applied to a 7 cm diameter area, with the chest tube entrance to the skin being considered as the center. Skin temperature will be measured with an infrared thermometer and will be ensured to reach 13.0 degrees. Ice pack application is expected to last approximately 9-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The chest tube removal procedure will be performed according to clinical routine practice. |
| EMLA cream | Experimental | EMLA cream will be applied to the chest tube area 3 hours before the chest tube removal procedure. Then, the chest tube removal procedure will be performed. Receives: Drug: EMLA Cream |
| Cold application | Experimental | Before the chest tube removal procedure, an ice cube pack will be applied to the chest tube area. Cold application will continue until the skin temperature drops to 13.0 degrees. Then the chest tube removal procedure will be performed. Receives: Procedure: Cold application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural pain score- Wong-Baker FACES Pain Rating Scale
The scale is used to diagnose pain in children aged 3-18 years. It consists of six facial expressions, each one representing an increasing degree of pain scored on a scale 0 to 5 from left to right. The first face is a happy face representing "no pain=0" while the last face is a crying face representing "the worst pain imaginable=5". Higher scores indicate low pain tolerance. Participants are asked to choose the facial expression that best represents their pain.
Measured: 3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
Secondary outcomes (3)
Procedural fear score- Children's Fear Scale (CFS)
The CFS was developed to measure fear and anxiety in children. It consists of five facial expressions that represent a range from neutral to extreme fear. It is scored between 0 and 4. Both researchers and family members can use the CFS to measure fear and anxiety in children before and during procedure.
Measured: 3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
Oxygen saturation
Children will be connected to a pulse oximeter monitor; oxygen saturation will be monitored before, during and after the procedure.
Measured: 3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
Pulse rate
Children will be connected to a pulse oximeter monitor; their pulse rate will be monitored before, during and after the procedure.
Measured: 3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start5 Apr 2025
- Primary completion5 Jul 2025
- Study completion5 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chest Tube RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to experimental and control groups using block randomization method. Age, sex and procedural fear variables will be used for block randomization. In order to reach the sample size calculated in the study, strata will be repeated two times (2X2X3X2) and 24 children will be included in each group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Aytekin Ozdemir, Istanbul Medeniyet University
- Investigators
- Aynur Aytekin Ozdemir, Study director, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913855
- Sponsor's protocol ID
- 2023-61
- Status last verified
- Jul 2025
- First submitted
- 30 Mar 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
Publications
Rosen DA, Morris JL, Rosen KR, Valenzuela RC, Vidulich MG, Steelman RJ, Gustafson RA. Analgesia for pediatric thoracostomy tube removal. Anesth Analg. 2000 May;90(5):1025-8. doi: 10.1097/00000539-200005000-00005.
PubMed 10781447Pouraboli B, Mirlashari J, Fakhr AS, Ranjbar H, Ashtari S. The Effect of Facilitated Tucking on the Pain Intensity Induced by Chest Tube Removal in Infants. Adv Neonatal Care. 2022 Oct 1;22(5):467-472. doi: 10.1097/ANC.0000000000000936. Epub 2021 Aug 11.
PubMed 34387216
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of EMLA Cream and Cold Application on Pain, Fear and Vital Signs Before Chest Tube Removal in Children: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06913855
- Acronym / sponsor ID
- 2023-61
- Conditions
- Chest Tube Removal, Children, Pain Management
- Keywords
- Chest tube removal, Children, Pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 5 Apr 2025 (actual)
- Primary completion
- 5 Jul 2025 (actual)
- Study completion
- 5 Jul 2025 (actual)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to determine the effect of EMLA cream and cold application on pain, fear and vital signs before chest tube removal in children aged 7-18 years.
Detailed description
A chest tube is a device used to drain air or fluid from the pleural cavity under sterile conditions by inserting a thin or thick tube. Chest tubes adhere to the endothelium of the chest cavity after insertion and while in place. For this reason, the pulling force applied when they are removed breaks these adhesions and causes intense, localised and transient acute pain. Chest tube removal pain, defined as one of the patient's worst life experiences related to the surgical procedure, is an iatrogenic pain caused by an invasive procedure. Therefore, chest tube removal is a painful, anxious and frightening experience for the patient. There are few studies of pharmacological and non-pharmacological methods of pain control during chest tube removal in children. However, the management of pain associated with surgical procedures in childhood is very important for the management of pain, anxiety and fear that children will experience with future medical procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be assigned to experimental and control groups using block randomization method. Age, sex and procedural fear variables will be used for block randomization. In order to reach the sample size calculated in the study, strata will be repeated two times (2X2X3X2) and 24 children will be included in each group.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The chest tube removal procedure will be performed according to clinical routine practice. |
| EMLA cream | Experimental | Drug: EMLA CreamEMLA cream will be applied to the chest tube area 3 hours before the chest tube removal procedure. Then, the chest tube removal procedure will be performed. |
| Cold application | Experimental | Procedure: Cold applicationBefore the chest tube removal procedure, an ice cube pack will be applied to the chest tube area. Cold application will continue until the skin temperature drops to 13.0 degrees. Then the chest tube removal procedure will be performed. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Having two chest tubes (mediastinal/pleural) placed after open heart surgery
- Turkish literate
- With stable vital signs
- Willing to participate in the research
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMLA CreamEMLA cream is applied once, 3 hours before the tube is removed. EMLA cream will be applied by the researcher in a thin layer to an area of 7-10 cm2, with the chest tube entrance to the skin remaining in the center. It will be covered with a Tegaderm transparent film dressing. | Drug | EMLA cream |
| Cold applicationCold application will be made with an ice cube pack immediately before the chest tube removal procedure. Cold application will be applied to a 7 cm diameter area, with the chest tube entrance to the skin being considered as the center. Skin temperature will be measured with an infrared thermometer and will be ensured to reach 13.0 degrees. Ice pack application is expected to last approximately 9-10 minutes. | Procedure or surgery | Cold application |
Primary outcome
Procedural pain score- Wong-Baker FACES Pain Rating Scale
Time frame: 3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
The scale is used to diagnose pain in children aged 3-18 years. It consists of six facial expressions, each one representing an increasing degree of pain scored on a scale 0 to 5 from left to right. The first face is a happy face representing "no pain=0" while the last face is a crying face representing "the worst pain imaginable=5". Higher scores indicate low pain tolerance. Participants are asked to choose the facial expression that best represents their pain.
3 secondary outcomes
Procedural fear score- Children's Fear Scale (CFS)
Time frame: 3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
Oxygen saturation
Time frame: 3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
Pulse rate
Time frame: 3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Results publication: PubMed 10781447Rosen DA, Morris JL, Rosen KR, Valenzuela RC, Vidulich MG, Steelman RJ, Gustafson RA. Analgesia for pediatric thoracostomy tube removal. Anesth Analg. 2000 May;90(5):1025-8. doi: 10.1097/00000539-200005000-00005.
- Results publication: PubMed 34387216Pouraboli B, Mirlashari J, Fakhr AS, Ranjbar H, Ashtari S. The Effect of Facilitated Tucking on the Pain Intensity Induced by Chest Tube Removal in Infants. Adv Neonatal Care. 2022 Oct 1;22(5):467-472. doi: 10.1097/ANC.0000000000000936. Epub 2021 Aug 11.
- Individual participant dataSharing planned: Yes. Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
Related trials for Chest Tube Removal
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
Recruiting
Effect of Box Breathing Before Chest Tube Removal After Open-Heart Surgery
Open-Heart Surgery
Recruiting
The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters
Congenital Heart Disease (CHD), Chest Tube Removal
Active, not recruiting
Effects of Vibration and Breathing Exercises on Pain and Anxiety During Chest Tube Removal
Postoperative Pain, Anxiety
Recruiting
Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries
Lung Pathologies of Unclear Etiology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aynur Aytekin Ozdemir study director
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMLA Cream and Cold application in people with Chest Tube Removal and Children, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural pain score- Wong-Baker FACES Pain Rating Scale (time frame: 3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06913855, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.