Child, Hospitalized
Conditions
Keywords
Children, venipuncture related pain and stress, EMLA, distraction techniques
Brief 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.
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.
Interventions
DRUGEMLA application
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.
BEHAVIORALDistraction techniques
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.
OTHEREMLA cream and distraction techniques
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.
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Children aged 3-16 years who receive first peripheral intravenous puncture during hospitalization.
Exclusion criteria
1. Emergency peripheral intravenous puncture. 2. Allergic history for lidocaine cream. 3. Presence of cognitive impairment, hearing impairment or visual impairment. 4. Children who were discharged from the hospital after participating in the experiment but were readmitted due to illness. 5. Refuse to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale | 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) | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retaining Time of Intravenous Cannula | When the needle is removed. | Time (hours) from needle insertion to remove. |
| Concentration of Salivary Cortisol | Immediately after children reporting pain score | 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 |
| Venipuncture Duration | During children's first venipuncture | record how long is children's first venipuncture duration |
| Heart Rate | During the peripheral intravenous insertion procedure. | 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. |
| Pulse Oximetry Saturation | During the peripheral intravenous insertion procedure. | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 103 |
| 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 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. | 96 |
| 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. | 100 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Failed specimen of saliva | 4 | 3 | 4 |
| Overall Study | First venipuncture failed | 4 | 6 | 5 |
| Overall Study | Unscheduled venipuncture | 9 | 13 | 7 |
Baseline characteristics
| Characteristic | EMLA Group | Distraction Group | Combined Group | Total |
|---|---|---|---|---|
| Age | 105.8 Months | 108.4 Months | 104.6 Months | 106.1 Months |
| Age, Continuous | 105.8 Months STANDARD_DEVIATION 42.1 | 108.4 Months STANDARD_DEVIATION 40.4 | 104.6 Months STANDARD_DEVIATION 46.4 | 106.1 Months STANDARD_DEVIATION 43 |
| Age, Customized Adolescence | 16 Participants | 18 Participants | 18 Participants | 52 Participants |
| Age, Customized Preschool age | 40 Participants | 29 Participants | 42 Participants | 111 Participants |
| Age, Customized School age | 47 Participants | 49 Participants | 40 Participants | 136 Participants |
| Race/Ethnicity, Customized Han | 100 Participants | 94 Participants | 98 Participants | 292 Participants |
| Race/Ethnicity, Customized Miao | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized others | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Uyghur | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Zhuang | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment China | 103 Participants | 96 Participants | 100 Participants | 299 Participants |
| Sex: Female, Male Female | 47 Participants | 40 Participants | 45 Participants | 132 Participants |
| Sex: Female, Male Male | 56 Participants | 56 Participants | 55 Participants | 167 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 96 | 0 / 100 |
| other Total, other adverse events | 0 / 103 | 0 / 96 | 0 / 100 |
| serious Total, serious adverse events | 0 / 103 | 0 / 96 | 0 / 100 |
Outcome results
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).
Time frame: Immediately after completing peripheral venipuncture.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EMLA Group | Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale | 2 score on a scale |
| Distraction Group | Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale | 2 score on a scale |
| Combined Group | Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale | 2 score on a scale |
p-value: 0.511Kruskal-Wallis
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
Time frame: Immediately after completing peripheral venipuncture.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EMLA Group | Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | 1 score on a scale |
| Distraction Group | Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | 1 score on a scale |
| Combined Group | Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | 1 score on a scale |
p-value: 0.906Kruskal-Wallis
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.
Time frame: Immediately after completing all participants' interventions.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EMLA Group | Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | 0 score on a scale |
| Distraction Group | Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | 0 score on a scale |
| Combined Group | Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | 0 score on a scale |
p-value: 0.072Kruskal-Wallis
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
Time frame: Immediately after children reporting pain score
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EMLA Group | Concentration of Salivary Cortisol | 35.47 percentage of salivary cortisol |
| Distraction Group | Concentration of Salivary Cortisol | 32.02 percentage of salivary cortisol |
| Combined Group | Concentration of Salivary Cortisol | 37.7 percentage of salivary cortisol |
p-value: 0.035Kruskal-Wallis
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.
Time frame: During the peripheral intravenous insertion procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EMLA Group | Heart Rate | 104.02 beat per minute | Standard Deviation 19.5 |
| Distraction Group | Heart Rate | 102.49 beat per minute | Standard Deviation 17.72 |
| Combined Group | Heart Rate | 103.65 beat per minute | Standard Deviation 20.17 |
p-value: 0.844ANOVA
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.
Time frame: During the peripheral intravenous insertion procedure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EMLA Group | Pulse Oximetry Saturation | 98 percent of oxyhemoglobin |
| Distraction Group | Pulse Oximetry Saturation | 98 percent of oxyhemoglobin |
| Combined Group | Pulse Oximetry Saturation | 99 percent of oxyhemoglobin |
p-value: 0.438Kruskal-Wallis
Secondary
Retaining Time of Intravenous Cannula
Time (hours) from needle insertion to remove.
Time frame: When the needle is removed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EMLA Group | Retaining Time of Intravenous Cannula | 15 hours |
| Distraction Group | Retaining Time of Intravenous Cannula | 15 hours |
| Combined Group | Retaining Time of Intravenous Cannula | 21 hours |
p-value: 0.843Kruskal-Wallis
Secondary
Venipuncture Duration
record how long is children's first venipuncture duration
Time frame: During children's first venipuncture
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EMLA Group | Venipuncture Duration | 83 seconds |
| Distraction Group | Venipuncture Duration | 83 seconds |
| Combined Group | Venipuncture Duration | 85.5 seconds |
p-value: 0.44Kruskal-Wallis