AICDS Implantation Pediatrics, Analgesia After Pacemaker
Conditions
Keywords
pacemaker, AICDS, regional anesthesia
Brief summary
The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a decrease in amount of narcotic medications need and track complications.
Interventions
DRUGLA group
In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
DRUGB Group
In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing implantation or revision of pacemaker or AICD in the pediatric cath lab
Exclusion criteria
* parent or patient refusal * use of narcotic medications prior to procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram | From 24 hours after procedure to 48 hours after procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain as Measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale | up to 6 hours post procedure in post anesthesia care unit (PACU) | Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment measures pain with a total score that ranges from 0 to 10; a higher score indicating greater pain. |
| Number of Patients With the Incidence of Pruritis | up to 48 hours after procedure | — |
| Number of Patients With the Incidence of Nausea/Vomiting | up to 48 hours after procedure | — |
| Pain as Measured by the Visual Analog Scale (VAS) Pain Score | up to 1.5 hours post procedure in post anesthesia care unit (PACU) | VAS pain scale is a range of scores from 0-100. A higher score indicates greater pain intensity. |
| Number of Patients With Local Anesthetic Toxicity | up to 48 hours after procedure | — |
| Number of Patients With Incidence of Pneumothorax | up to 48 hours after procedure | — |
| Number of Patients With Respiratory Depression | up to 48 hours after procedure | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Local Anesthetic (LA Group) LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site. | 10 |
| B Group B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves. | 9 |
| Total | 19 |
Baseline characteristics
| Characteristic | B Group | Total | Local Anesthetic (LA Group) |
|---|---|---|---|
| Age, Continuous | 8.77 years STANDARD_DEVIATION 3.96 | 11.05 years STANDARD_DEVIATION 4.02 | 13.10 years STANDARD_DEVIATION 2.92 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 9 participants | 19 participants | 10 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 1 Participants |
| Sex: Female, Male Male | 4 Participants | 13 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 |
Outcome results
Primary
Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram
Time frame: From 24 hours after procedure to 48 hours after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthetic (LA Group) | Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram | 0.035 MME per kg | Standard Deviation 0.082 |
| B Group | Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram | 0.008 MME per kg | Standard Deviation 0.026 |
Primary
Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram
Time frame: up to 24 hours after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthetic (LA Group) | Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram | 0.021 MME per kg | Standard Deviation 0.044 |
| B Group | Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram | 0.008 MME per kg | Standard Deviation 0.026 |
Secondary
Number of Patients With Incidence of Pneumothorax
Time frame: up to 48 hours after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Local Anesthetic (LA Group) | Number of Patients With Incidence of Pneumothorax | 0 Participants |
| B Group | Number of Patients With Incidence of Pneumothorax | 0 Participants |
Secondary
Number of Patients With Local Anesthetic Toxicity
Time frame: up to 48 hours after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Local Anesthetic (LA Group) | Number of Patients With Local Anesthetic Toxicity | 0 Participants |
| B Group | Number of Patients With Local Anesthetic Toxicity | 0 Participants |
Secondary
Number of Patients With Respiratory Depression
Time frame: up to 48 hours after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Local Anesthetic (LA Group) | Number of Patients With Respiratory Depression | 0 Participants |
| B Group | Number of Patients With Respiratory Depression | 0 Participants |
Secondary
Number of Patients With the Incidence of Nausea/Vomiting
Time frame: up to 48 hours after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Local Anesthetic (LA Group) | Number of Patients With the Incidence of Nausea/Vomiting | 0 Participants |
| B Group | Number of Patients With the Incidence of Nausea/Vomiting | 0 Participants |
Secondary
Number of Patients With the Incidence of Pruritis
Time frame: up to 48 hours after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Local Anesthetic (LA Group) | Number of Patients With the Incidence of Pruritis | 0 Participants |
| B Group | Number of Patients With the Incidence of Pruritis | 0 Participants |
Secondary
Pain as Measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale
Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment measures pain with a total score that ranges from 0 to 10; a higher score indicating greater pain.
Time frame: up to 6 hours post procedure in post anesthesia care unit (PACU)
Population: Data were not collected from 3 participants in the Local Anesthetic (LA Group) arm because it was not charted by bedside nurse. Data were not collected from 1 participant in the B group arm because it was not charted by bedside nurse.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthetic (LA Group) | Pain as Measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale | 1.28 score on a scale | Standard Deviation 2.36 |
| B Group | Pain as Measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale | 1.62 score on a scale | Standard Deviation 2.92 |
Secondary
Pain as Measured by the Visual Analog Scale (VAS) Pain Score
VAS pain scale is a range of scores from 0-10. A higher score indicates greater pain intensity.
Time frame: up to 24 hours post procedure
Population: Data were not collected from 1 participant in the Local Anesthetic (LA Group) arm because it was not charted by bedside nurse.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthetic (LA Group) | Pain as Measured by the Visual Analog Scale (VAS) Pain Score | 1.33 score on a scale | Standard Deviation 2.23 |
| B Group | Pain as Measured by the Visual Analog Scale (VAS) Pain Score | 3.44 score on a scale | Standard Deviation 3.46 |
Secondary
Pain as Measured by the Visual Analog Scale (VAS) Pain Score
VAS pain scale is a range of scores from 0-100. A higher score indicates greater pain intensity.
Time frame: up to 1.5 hours post procedure in post anesthesia care unit (PACU)
Population: Data were not collected for this outcome measure because this assessment was not used in the PACU. The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale was used instead.