Child, HospitalizedNCT04275336
Pharmacological and Non-pharmacological Interventions in Management of Venipuncture Pain.
A study testing EMLA application, Distraction techniques and EMLA cream and distraction techniques in people with Child, Hospitalized, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
To evaluate whether an integration of pharmacological and non- pharmacological interventions is more effective than either one of intervention in pain reduction during pediatric peripheral venipuncture. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Child, Hospitalized
- What is being tested?
- EMLA application, Distraction techniques and EMLA cream and distraction techniques
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 12 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3-16 years who receive first peripheral intravenous puncture during hospitalization.
Who cannot join
- Emergency peripheral intravenous puncture.
- Allergic history for lidocaine cream.
- Presence of cognitive impairment, hearing impairment or visual impairment.
- Children who were discharged from the hospital after participating in the experiment but were readmitted due to illness.
- Refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Pharmacological and Non-pharmachological Interventions in Management of Peripheral Venipuncture Related Pain: a Randomized Clinical Trial
To evaluate whether an integration of pharmacological and non- pharmacological interventions is more effective than either one of intervention in pain reduction during pediatric peripheral venipuncture.
Read the detailed description
Intravenous infusion is a routing practice of drug administration for hospitalized children.However numerous studies have shown that venipuncture is a major source of pain of children during their hospitalization which can lead to moderate to severe pain and cause fear, stress and anxiety in children if there is no effective pain management.
The current pain relieving methods include pharmacological (i.e. topical anesthetic) and non-pharmnacological (i.e. distraction techniques) interventions. pharmacological There are scarce evidences supporting that a combination of pharmacological and non-pharmacological interventions can enhance children's abilities in coping with their pain and stress during the venipuncture. EMLA cream is a main pharmacological intervention in managing needle-related pain which can penetrate the cuticle and epidermal layer of intact skin, enter the dermis where nerve endings are located, and relieve pain. However pharmacological interventions have proven inadequate in mitigating pain and stress.The main non-pharmacological alternatives is distraction techniques. There are extremely limited data studies on merging pharmacological and non-pharmacological interventions to compensate for each other's inadequacies. Hence, this study aimed to evaluate the effect of combining both topical anesthetic and distraction techniques in comparison with either of the interventions applied singly.
This study adopts a randomized, blind, controlled intervention trial. Participants will be randomly assigned to three groups: EMLA group, Distraction group and Combined group (EMLA cream plus distraction techniques). The outcomes will be measured by self-reported pain, parent-reported pain and observer-reported pain. Salivary cortisol level will be measured by the ultra sensitive Cortisol Saliva ELISA Assay Kit. Other physiological metrics like heart rate, SpO2, and other intravenous cannulation factors will be rated and recorded.
- Conditions
- Child, Hospitalized
- Being tested
- EMLA application, Distraction techniques, EMLA cream and distraction techniques
- Keywords
- Children, venipuncture related pain and stress, EMLA, distraction techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLA applicationDrug
Also called EMLA cream
A thick layer of cream (lidocaine and propiocaine 2.5%/2.5%) will be applied on a 1x1 cm2 area of skin on the cannulation site. The transparent dressing will be left in place for 30 minutes, then remove and clean with a sterile cotton swab. Then nurse perform IV cannulation for them.
Distraction techniquesBehavioural
Also called Distractions
Multiple distractions including toy whistles, cartoon books, a TV showing cartoons, and various electronic products with video games will be provided for the children to choose and play with. They will also be taught breathing exercises (i.e. inhaling through the nose for 3 seconds and exhaling for 5 seconds, while they are counting) if they are willing. A play therapist play with the children for 5 min. prior to and throughout the venipuncture procedure.
EMLA cream and distraction techniquesOther
Also called EMLA cream and distractions
both EMLA cream and distraction techniques will be used. EMLA cream will be applied on the pre-puncture site for 30 minutes as the EMLA group, then 5 minutes before the venipuncture, the play therapist encourage them to choose their favorite toys to play with or to learn breathing exercises. During IV cannulation the play therapist will also continue distracting the child with toys.
| Study group | Role | What they receive |
|---|---|---|
| EMLA group | Experimental | The specialist nurse who is to perform IV cannulation determine the puncture site. A thick layer of cream (lidocaine and propiocaine 2.5%/2.5%) will be applied on a 1x1 cm2 area of skin on the cannulation site. The transparent dressing will be left in place for 30 minutes, then remove and clean with a sterile cotton swab. Then nurse performed IV cannulation for them. Receives: Drug: EMLA application |
| Distraction group | Experimental | The multiple distractions including toy whistles, cartoon books, a TV showing cartoons, and various electronic products with video games will be provided for the children to choose and play with. They are also taught breathing exercises (i.e. inhaling through the nose for 3 seconds and exhaling for 5 seconds, while they are counting) if they are willing. A play therapist play with the children for 5 min. prior to and throughout the venipuncture procedure. Receives: Behavioral: Distraction techniques |
| Combined group | Experimental | both EMLA cream and distraction techniques will be used. EMLA cream will be applied on the pre-puncture site for 30 minutes as the EMLA group, then 5 minutes before the venipuncture, the play therapist encourage them to choose their favorite toys to play with or to learn breathing exercises. During IV cannulation the play therapist will also continue distracting the child with toys. Receives: Other: EMLA cream and distraction techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale
Pain outcomes are assessed by child himself or herself using Wong-Baker Faces Pain Rating Scale. The scale includes 6 facial expressions with correlating numbers of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot), 10(hurts worst). Children pick a facial expression, that corresponds with their pain and see a number that matches it. The minimum value is 0 and the maximum value is 10, the higher score means a worse outcome (children having higher level of pain).
Measured: Immediately after completing peripheral venipuncture.
Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC)
The effectiveness is analyzed by outcomes assessors using r-FLACC via video taken during the procedure. The outcomes assessor is blind for the study design. The r-FLACC is a tool which evaluates pain-related behavior on facial expression, leg movement, activity, cry and consolability. Total score of the scale is summed in range 0 to 10. 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.the higher scores mean a worse outcome.
Measured: Immediately after completing all participants' interventions.
Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC)
Pain outcomes are assessed by parents using the r-FLACC scale. The r-FLACC is a tool which evaluates pain-related behavior on facial expression, leg movement, activity, cry and consolability. Total score of the scale is summed in range 0 to 10. 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain. The higher scores means a worse outcome
Measured: Immediately after completing peripheral venipuncture.
Secondary outcomes (5)
Concentration of Salivary Cortisol
Physiological stress levels are measured by means of salivary cortisol as an indicator. The salivary samples (1-2 milliliter) are taken with sterile collection devices immediately after children reporting pain score. The salivary samples are immediately stored at -20℃ freezer. Cortisol levels are determined by human salivary cortisol ELISA Kit (Jianglai, Shanghai, China). This si no cut-off score and the higher scores means a worse outcomes
Measured: Immediately after children reporting pain score
Heart Rate
Evaluate the physiological response (heart rate) caused by peripheral intravenous puncture. A portable recording pulse oximeter is connected to children's index finger. Heart rate (beats per minute) is measured and recorded.
Measured: During the peripheral intravenous insertion procedure.
Pulse Oximetry Saturation
Evaluate the physiological response (pulse oximetry saturation) secondary to peripheral intravenous puncture. A portable recording pulse oximeter is connected to children's index finger. Pulse oximetry saturation（percentage）is measured and recorded.
Measured: During the peripheral intravenous insertion procedure.
Retaining Time of Intravenous Cannula
Time (hours) from needle insertion to remove.
Measured: When the needle is removed.
Venipuncture Duration
record how long is children's first venipuncture duration
Measured: During children's first venipuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Feb 2020
- Primary completion30 Apr 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child, HospitalizedStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Gu, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275336
- Sponsor's protocol ID
- FNF201829
- Status last verified
- Sep 2023
- First submitted
- 6 Feb 2020
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu Z, Zhou Y, Xu X, Lin L, Le Q, Gu Y. Pharmacological and non-pharmacological interventions in management of peripheral venipuncture-related pain: a randomized clinical trial. BMC Pediatr. 2023 Feb 3;23(1):58. doi: 10.1186/s12887-023-03855-z.
PubMed 36737707
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological and Non-pharmachological Interventions in Management of Peripheral Venipuncture Related Pain: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04275336
- Acronym / sponsor ID
- FNF201829
- Conditions
- Child, Hospitalized
- Keywords
- Children, venipuncture related pain and stress, EMLA, distraction techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Posted 6 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate whether an integration of pharmacological and non- pharmacological interventions is more effective than either one of intervention in pain reduction during pediatric peripheral venipuncture.
Detailed description
Intravenous infusion is a routing practice of drug administration for hospitalized children.However numerous studies have shown that venipuncture is a major source of pain of children during their hospitalization which can lead to moderate to severe pain and cause fear, stress and anxiety in children if there is no effective pain management.
The current pain relieving methods include pharmacological (i.e. topical anesthetic) and non-pharmnacological (i.e. distraction techniques) interventions. pharmacological There are scarce evidences supporting that a combination of pharmacological and non-pharmacological interventions can enhance children's abilities in coping with their pain and stress during the venipuncture. EMLA cream is a main pharmacological intervention in managing needle-related pain which can penetrate the cuticle and epidermal layer of intact skin, enter the dermis where nerve endings are located, and relieve pain. However pharmacological interventions have proven inadequate in mitigating pain and stress.The main non-pharmacological alternatives is distraction techniques. There are extremely limited data studies on merging pharmacological and non-pharmacological interventions to compensate for each other's inadequacies. Hence, this study aimed to evaluate the effect of combining both topical anesthetic and distraction techniques in comparison with either of the interventions applied singly.
This study adopts a randomized, blind, controlled intervention trial. Participants will be randomly assigned to three groups: EMLA group, Distraction group and Combined group (EMLA cream plus distraction techniques). The outcomes will be measured by self-reported pain, parent-reported pain and observer-reported pain. Salivary cortisol level will be measured by the ultra sensitive Cortisol Saliva ELISA Assay Kit. Other physiological metrics like heart rate, SpO2, and other intravenous cannulation factors will be rated and recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EMLA group | Experimental | Drug: EMLA applicationThe specialist nurse who is to perform IV cannulation determine the puncture site. A thick layer of cream (lidocaine and propiocaine 2.5%/2.5%) will be applied on a 1x1 cm2 area of skin on the cannulation site. The transparent dressing will be left in place for 30 minutes, then remove and clean with a sterile cotton swab. Then nurse performed IV cannulation for them. |
| Distraction group | Experimental | Behavioral: Distraction techniquesThe multiple distractions including toy whistles, cartoon books, a TV showing cartoons, and various electronic products with video games will be provided for the children to choose and play with. They are also taught breathing exercises (i.e. inhaling through the nose for 3 seconds and exhaling for 5 seconds, while they are counting) if they are willing. A play therapist play with the children for 5 min. prior to and throughout the venipuncture procedure. |
| Combined group | Experimental | Other: EMLA cream and distraction techniquesboth EMLA cream and distraction techniques will be used. EMLA cream will be applied on the pre-puncture site for 30 minutes as the EMLA group, then 5 minutes before the venipuncture, the play therapist encourage them to choose their favorite toys to play with or to learn breathing exercises. During IV cannulation the play therapist will also continue distracting the child with toys. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 3-16 years who receive first peripheral intravenous puncture during hospitalization.
Key exclusion criteria (5 listed)
- Emergency peripheral intravenous puncture.
- Allergic history for lidocaine cream.
- Presence of cognitive impairment, hearing impairment or visual impairment.
- Children who were discharged from the hospital after participating in the experiment but were readmitted due to illness.
- Refuse to participate in the study.
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 applicationAlso: EMLA creamA thick layer of cream (lidocaine and propiocaine 2.5%/2.5%) will be applied on a 1x1 cm2 area of skin on the cannulation site. The transparent dressing will be left in place for 30 minutes, then remove and clean with a sterile cotton swab. Then nurse perform IV cannulation for them. | Drug | EMLA group |
| Distraction techniquesAlso: DistractionsMultiple distractions including toy whistles, cartoon books, a TV showing cartoons, and various electronic products with video games will be provided for the children to choose and play with. They will also be taught breathing exercises (i.e. inhaling through the nose for 3 seconds and exhaling for 5 seconds, while they are counting) if they are willing. A play therapist play with the children for 5 min. prior to and throughout the venipuncture procedure. | Behavioural | Distraction group |
| EMLA cream and distraction techniquesAlso: EMLA cream and distractionsboth EMLA cream and distraction techniques will be used. EMLA cream will be applied on the pre-puncture site for 30 minutes as the EMLA group, then 5 minutes before the venipuncture, the play therapist encourage them to choose their favorite toys to play with or to learn breathing exercises. During IV cannulation the play therapist will also continue distracting the child with toys. | Other | Combined group |
Primary outcome
Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale
Time frame: Immediately after completing peripheral venipuncture.
Pain outcomes are assessed by child himself or herself using Wong-Baker Faces Pain Rating Scale. The scale includes 6 facial expressions with correlating numbers of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot), 10(hurts worst). Children pick a facial expression, that corresponds with their pain and see a number that matches it. The minimum value is 0 and the maximum value is 10, the higher score means a worse outcome (children having higher level of pain).
Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC)
Time frame: Immediately after completing all participants' interventions.
The effectiveness is analyzed by outcomes assessors using r-FLACC via video taken during the procedure. The outcomes assessor is blind for the study design. The r-FLACC is a tool which evaluates pain-related behavior on facial expression, leg movement, activity, cry and consolability. Total score of the scale is summed in range 0 to 10. 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.the higher scores mean a worse outcome.
Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC)
Time frame: Immediately after completing peripheral venipuncture.
Pain outcomes are assessed by parents using the r-FLACC scale. The r-FLACC is a tool which evaluates pain-related behavior on facial expression, leg movement, activity, cry and consolability. Total score of the scale is summed in range 0 to 10. 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain. The higher scores means a worse outcome
5 secondary outcomes
Concentration of Salivary Cortisol
Time frame: Immediately after children reporting pain score
Heart Rate
Time frame: During the peripheral intravenous insertion procedure.
Pulse Oximetry Saturation
Time frame: During the peripheral intravenous insertion procedure.
Retaining Time of Intravenous Cannula
Time frame: When the needle is removed.
Venipuncture Duration
Time frame: During children's first venipuncture
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36737707Yu Z, Zhou Y, Xu X, Lin L, Le Q, Gu Y. Pharmacological and non-pharmacological interventions in management of peripheral venipuncture-related pain: a randomized clinical trial. BMC Pediatr. 2023 Feb 3;23(1):58. doi: 10.1186/s12887-023-03855-z.
- Individual participant dataSharing planned: No
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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.
Ying Gu study chair
Children's Hospital of Fudan 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 application, Distraction techniques and EMLA cream and distraction techniques in people with Child, Hospitalized, run by Children's Hospital of Fudan University at 1 site in China.
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 1 inclusion and 5 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 21 Sep 2023. 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 China. 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?
Yes. Results are posted in the registry (first posted 6 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale (time frame: Immediately after completing peripheral venipuncture.). The study lists 3 primary outcomes in all. 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 NCT04275336, which also lists 1 linked publication.
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 21 Sep 2023.