Trial Outcomes & Findings for Pharmacological and Non-pharmacological Interventions in Management of Venipuncture Pain. (NCT NCT04275336)
NCT ID: NCT04275336
Last Updated: 2023-09-21
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
354 participants
Primary outcome timeframe
Immediately after completing peripheral venipuncture.
Results posted on
2023-09-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
120
|
118
|
116
|
|
Overall Study
COMPLETED
|
103
|
96
|
100
|
|
Overall Study
NOT COMPLETED
|
17
|
22
|
16
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
First venipuncture failed
|
4
|
6
|
5
|
|
Overall Study
Unscheduled venipuncture
|
9
|
13
|
7
|
|
Overall Study
Failed specimen of saliva
|
4
|
3
|
4
|
Baseline Characteristics
Pharmacological and Non-pharmacological Interventions in Management of Venipuncture Pain.
Baseline characteristics by cohort
| Measure |
EMLA Group
n=103 Participants
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.
|
Distraction Group
n=96 Participants
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.
|
Combined Group
n=100 Participants
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.
|
Total
n=299 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
105.8 Months
STANDARD_DEVIATION 42.1 • n=5 Participants
|
108.4 Months
STANDARD_DEVIATION 40.4 • n=7 Participants
|
104.6 Months
STANDARD_DEVIATION 46.4 • n=5 Participants
|
106.1 Months
STANDARD_DEVIATION 43.0 • n=4 Participants
|
|
Age, Customized
Preschool age
|
40 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Age, Customized
School age
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Age, Customized
Adolescence
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Han
|
100 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
292 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Uyghur
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Zhuang
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Miao
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
others
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
103 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
299 Participants
n=4 Participants
|
|
Age
|
105.8 Months
n=5 Participants
|
108.4 Months
n=7 Participants
|
104.6 Months
n=5 Participants
|
106.1 Months
n=4 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
EMLA Group
n=103 Participants
Use EMLA cream in the management of peripheral venipuncture pain.
A eutectic mixture of local anesthetics (EMLA) cream containing 25mg lidocaine and 25mg propiocaine per gram will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter.
|
Distraction Group
n=96 Participants
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.
|
Combined Group
n=100 Participants
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.
|
|---|---|---|---|
|
Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale
|
2 score on a scale
Interval 0.0 to 2.0
|
2 score on a scale
Interval 0.0 to 2.0
|
2 score on a scale
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
EMLA Group
n=103 Participants
Use EMLA cream in the management of peripheral venipuncture pain.
A eutectic mixture of local anesthetics (EMLA) cream containing 25mg lidocaine and 25mg propiocaine per gram will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter.
|
Distraction Group
n=96 Participants
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.
|
Combined Group
n=100 Participants
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.
|
|---|---|---|---|
|
Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC)
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
EMLA Group
n=103 Participants
Use EMLA cream in the management of peripheral venipuncture pain.
A eutectic mixture of local anesthetics (EMLA) cream containing 25mg lidocaine and 25mg propiocaine per gram will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter.
|
Distraction Group
n=96 Participants
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.
|
Combined Group
n=100 Participants
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.
|
|---|---|---|---|
|
Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC)
|
1 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.25 to 2.0
|
1 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Immediately after children reporting pain scorePhysiological 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
Outcome measures
| Measure |
EMLA Group
n=103 Participants
Use EMLA cream in the management of peripheral venipuncture pain.
A eutectic mixture of local anesthetics (EMLA) cream containing 25mg lidocaine and 25mg propiocaine per gram will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter.
|
Distraction Group
n=96 Participants
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.
|
Combined Group
n=100 Participants
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.
|
|---|---|---|---|
|
Concentration of Salivary Cortisol
|
35.47 percentage of salivary cortisol
Interval 27.05 to 43.225
|
32.02 percentage of salivary cortisol
Interval 24.525 to 40.7875
|
37.7 percentage of salivary cortisol
Interval 28.01 to 44.645
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
EMLA Group
n=103 Participants
Use EMLA cream in the management of peripheral venipuncture pain.
A eutectic mixture of local anesthetics (EMLA) cream containing 25mg lidocaine and 25mg propiocaine per gram will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter.
|
Distraction Group
n=96 Participants
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.
|
Combined Group
n=100 Participants
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.
|
|---|---|---|---|
|
Heart Rate
|
104.02 beat per minute
Standard Deviation 19.5
|
102.49 beat per minute
Standard Deviation 17.72
|
103.65 beat per minute
Standard Deviation 20.17
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
EMLA Group
n=103 Participants
Use EMLA cream in the management of peripheral venipuncture pain.
A eutectic mixture of local anesthetics (EMLA) cream containing 25mg lidocaine and 25mg propiocaine per gram will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter.
|
Distraction Group
n=96 Participants
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.
|
Combined Group
n=100 Participants
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.
|
|---|---|---|---|
|
Pulse Oximetry Saturation
|
98 percent of oxyhemoglobin
Interval 97.0 to 100.0
|
98 percent of oxyhemoglobin
Interval 97.0 to 100.0
|
99 percent of oxyhemoglobin
Interval 97.0 to 100.0
|
SECONDARY outcome
Timeframe: When the needle is removed.Time (hours) from needle insertion to remove.
Outcome measures
| Measure |
EMLA Group
n=103 Participants
Use EMLA cream in the management of peripheral venipuncture pain.
A eutectic mixture of local anesthetics (EMLA) cream containing 25mg lidocaine and 25mg propiocaine per gram will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter.
|
Distraction Group
n=96 Participants
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.
|
Combined Group
n=100 Participants
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.
|
|---|---|---|---|
|
Retaining Time of Intravenous Cannula
|
15 hours
Interval 5.0 to 47.0
|
15 hours
Interval 5.0 to 44.0
|
21 hours
Interval 5.0 to 52.0
|
SECONDARY outcome
Timeframe: During children's first venipuncturerecord how long is children's first venipuncture duration
Outcome measures
| Measure |
EMLA Group
n=103 Participants
Use EMLA cream in the management of peripheral venipuncture pain.
A eutectic mixture of local anesthetics (EMLA) cream containing 25mg lidocaine and 25mg propiocaine per gram will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter.
|
Distraction Group
n=96 Participants
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.
|
Combined Group
n=100 Participants
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.
|
|---|---|---|---|
|
Venipuncture Duration
|
83 seconds
Interval 70.0 to 100.0
|
83 seconds
Interval 70.0 to 96.0
|
85.5 seconds
Interval 74.0 to 98.75
|
Adverse Events
EMLA Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Distraction Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combined Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place