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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMLA application | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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 | Immediately after completing peripheral venipuncture. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Children aged 3-16 years who receive first peripheral intravenous puncture during hospitalization.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Gu | Children's Hospital of Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36737707 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | EMLA Group | Use EMLA cream in the management of peripheral venipuncture pain. EMLA cream will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter. |
| FG001 | Distraction Group | Use distraction techniques (books, toy whistle, cartoon animation, breathing exercises, electronic products）in the management of peripheral venipuncture pain. Distraction techniques: A trained play therapist will entertain and distract the child with psychological interventions (books, toy whistle, cartoon animation, breathing exercises, electronic products）starting 5 minutes before the procedure and ending when the child left the room after the procedure. Children can choose one or more. |
| FG002 | Combined Group | Use EMLA cream combined with psychological interventions in the management of peripheral venipuncture pain. EMLA combined with distraction techniques: EMLA cream will be applied on the venipuncture site for 30 minutes than play therapist will distract children with the toys(distraction techniques) children choose before 5 minutes and throughout the venipuncture procedure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | EMLA Group | Use EMLA cream in the management of peripheral venipuncture pain. EMLA cream will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter. |
| BG001 | Distraction Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Median | Inter-Quartile Range | score on a scale | Immediately after completing peripheral venipuncture. |
|
Throughout the venipuncture procedure and follow-up during children's whole hospitalization, up to 24h
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EMLA Group | Use EMLA cream in the management of peripheral venipuncture pain. EMLA cream will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms.Yu Zhuowen | Children's Hospital of Fudan University | 18017591126 | yzw100@126.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2020 | Jun 30, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 4, 2020 | Jun 30, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 |
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|
|
| Distraction techniques | Behavioral | 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 techniques | Other | 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. |
|
|
| 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. | 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. | During the peripheral intravenous insertion procedure. |
| Retaining Time of Intravenous Cannula | Time (hours) from needle insertion to remove. | When the needle is removed. |
| Venipuncture Duration | record how long is children's first venipuncture duration | During children's first venipuncture |
| Failed specimen of saliva |
|
Use distraction techniques (books, toy whistle, cartoon animation, breathing exercises, electronic products）in the management of peripheral venipuncture pain. Distraction techniques: A trained play therapist will entertain and distract the child with distraction techniques (books, toy whistle, cartoon animation, breathing exercises, electronic products）starting 5 minutes before the procedure and ending when the child left the room after the procedure. Children can choose one or more distraction toys. |
| BG002 | Combined Group | Use EMLA cream combined with distraction toys in the management of peripheral venipuncture pain. EMLA combined with distraction techniques: EMLA cream will be applied on the venipuncture site for 30 minutes than play therapist will distract children with the toys(distraction techniques) ,children choose before 5 minutes and throughout the venipuncture procedure. |
| BG003 | Total | Total of all reporting groups |
| Months |
|
| Age, Customized | children who were in their 36 to 83 months old are defined as preschool children; children who were in their 84 to 155 months old are defined as school-aged children; children who were in their 156 to 203 months old are defined as adolescents. researchers will collected the baseline characteristics using the demographic questionnaire before any intervention implementation. | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Age | Geometric Mean | Full Range | Months |
|
| OG001 | Distraction Group | Use distraction techniques (books, toy whistle, cartoon animation, breathing exercises, electronic products）in the management of peripheral venipuncture pain. distraction techniques: A trained play therapist will distract the child with distraction techniques (books, toy whistle, cartoon animation, breathing exercises, electronic products）starting 5 minutes before the procedure and throughout the whole venipuncture procedure. Children can choose one or more distractions techniques. |
| OG002 | Combined Group | Use EMLA cream combined with distraction techniques in the management of peripheral venipuncture pain. EMLA with distraction techniques: EMLA cream will be applied on the venipuncture site for 30 minutes than the play therapist will distract children using distraction techniques 5 minutes before and throughout the venipuncture. procedure. |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Immediately after completing all participants' interventions. |
|
|
|
|
| Primary | 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 | Posted | Median | Inter-Quartile Range | score on a scale | Immediately after completing peripheral venipuncture. |
|
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | percentage of salivary cortisol | Immediately after children reporting pain score |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | beat per minute | During the peripheral intravenous insertion procedure. |
|
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | percent of oxyhemoglobin | During the peripheral intravenous insertion procedure. |
|
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|
|
| Secondary | Retaining Time of Intravenous Cannula | Time (hours) from needle insertion to remove. | Posted | Median | Inter-Quartile Range | hours | When the needle is removed. |
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|
| Secondary | Venipuncture Duration | record how long is children's first venipuncture duration | Posted | Median | Inter-Quartile Range | seconds | During children's first venipuncture |
|
|
|
|
| 0 |
| 103 |
| 0 |
| 103 |
| 0 |
| 103 |
| EG001 | Distraction Group | Use distraction techniques (books, toy whistle, cartoon animation, breathing exercises, electronic products）in the management of peripheral venipuncture pain. Distraction techniques: A trained play therapist will entertain and distract the child with psychological interventions (books, toy whistle, cartoon animation, breathing exercises, electronic products）starting 5 minutes before the procedure and ending when the child left the room after the procedure. Children can choose one or more. | 0 | 96 | 0 | 96 | 0 | 96 |
| EG002 | Combined Group | Use EMLA cream combined with distraction in the management of peripheral venipuncture pain. EMLA combined with distraction techniques: EMLA cream will be applied on the venipuncture site for 30 minutes than play therapist will distract children with the toys(distraction techniques) children choose before 5 minutes and throughout the venipuncture procedure. | 0 | 100 | 0 | 100 | 0 | 100 |
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| Organic Chemicals |
| D011318 | Prilocaine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |