Post Operative Pain
Conditions
Keywords
developmental delay, cognitive impairment, pain control, post operative pain, opioid, pain assessment, Parent Nurse controlled Analgesic, patient controlled analgesic, children, pain, analgesic, safety, parent satisfaction, nurse satisfaction, Pediatric
Brief summary
The purpose of this study is to compare, the safety, efficacy and level of parent and nurse satisfaction with three methods of opioid administration post-operatively in children (4-18 years of age) with developmental delay.
Detailed description
Children with developmental delay are at higher risk for inadequate pain assessment and management. Patient controlled analgesia (PCA) allows patients to administer opioids by pushing a PCA button when needed. This eliminates the delay of waiting for a nurse to obtain and administer pain medication. PCA has been shown to be safe, effective, and superior to intramuscular, intermittent opioid dosing for pain management in children. Often, children with developmental delays cannot operate a PCA independently, can not self report their pain and are often given pain medication as needed through an IV. Parent/Nurse Controlled Analgesia (PNCA) allows parents and nurses to push the PCA button for patients who are not able to do so themselves. This way of giving pain medicine has not been thoroughly studied. Some healthcare professionals use PNCA for these children, others do not. This study is being done to compare PNCA & intermittent opioid administration. Participants will be randomized into one of the three study groups: 1. Parent/Nurse controlled Analgesia (PNCA) with a continuous intravenous (IV)infusion of pain medicine. 2. PNCA without continuous IV infusion of pain medicine. 3. Pain medicine given through IV administered on an as needed basis(PRN) by the nurse. The Acute Pain Service will follow all three groups of patients throughout the study. This team specializes in the management of children's pain. Pain team is also available 24 hours a day, 7 days a week. The study will continue until child can tolerate pain medication in his/her stomach. Data will be collected regarding safety, efficacy, parent & Nurse satisfaction.
Interventions
OTHERPain and standard side effect management for PNCA with basal method.
Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects. Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure.
OTHERPain and standard side effect management with PNCA without basal
Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects. Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure.
OTHERPain and standard side effect management with IV on an as needed basis method.
Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects. Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol.
Sponsors
Children's Hospital and Health System Foundation, Wisconsin
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children with developmental delay between 4 and 18 years of age who are unable to operate PCA due to developmental delay. * Children scheduled for surgery anticipated to require \>24hour stay with anticipation of IV narcotics will be required. * Children whose parents are able to verbalize an understanding of PNCA. * Parents with fluency in english(both speaking and writing).
Exclusion criteria
* Patients who do not meet inclusion criteria * Patients whose parents do not give informed consent * patients allergic to both morphine and hydromorphone * patients with severe physiologically altering obstructive sleep apnea * Patients who are or are expected to remain on a ventilator * Patients receiving an epidural -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale | First 24 hours on study | Pain is measured with the Face, Legs, Activity, Cry, Consolability scale (FLACC) is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The median pain score over the first shift (24 hours) is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Requiring Naloxone for Respiratory Depression | Daily, for up to 3 days | Number of patients requiring naloxone for respiratory depression (our most important side effect) |
| Parent Satisfaction With the Administration Technique | parents, once at the end of study | Parents were asked Overall, how satisfied were you with the pain relief your child received after surgery? Response options were: 1. Very Dissatisfied, 2. Dissatisfied, 3. Satisfied, 4. Very Satisfied. Responses were scored on a 1-4 scale, with Very Dissatisfied = 1; Dissatisfied = 2; Satisfied = 3; Very Satisfied = 4. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| I PNCA With Basal Parent and Nurse Controlled Analgesics with basal
Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure. | 22 |
| II PNCA w/o Basal Parent and Nurse Controlled Analgesics without basal
Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure. | 30 |
| III PRN Intermittent Intermittent opioid administered IV on an as needed basis
Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. | 28 |
| Total | 80 |
Baseline characteristics
| Characteristic | II PNCA w/o Basal | III PRN Intermittent | I PNCA With Basal | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 28 Participants | 22 Participants | 80 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12 years | 12 years | 10.5 years | 12 years |
| Region of Enrollment United States | 30 participants | 28 participants | 22 participants | 80 participants |
| Sex: Female, Male Female | 15 Participants | 11 Participants | 8 Participants | 34 Participants |
| Sex: Female, Male Male | 15 Participants | 17 Participants | 14 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 34 | 0 / 33 |
| serious Total, serious adverse events | 1 / 27 | 0 / 34 | 0 / 33 |
Outcome results
Primary
Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale
Pain is measured with the Face, Legs, Activity, Cry, Consolability scale (FLACC) is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The median pain score over the first shift (24 hours) is reported.
Time frame: First 24 hours on study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PNCA With Basal | Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale | 1.0 units on a scale |
| PNCA Without Basal | Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale | 1.8 units on a scale |
| Intermittent Opioid on as Needed Basis | Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale | 1.5 units on a scale |
Secondary
Number of Patients Requiring Naloxone for Respiratory Depression
Number of patients requiring naloxone for respiratory depression (our most important side effect)
Time frame: Daily, for up to 3 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PNCA With Basal | Number of Patients Requiring Naloxone for Respiratory Depression | 1 Participants |
| PNCA Without Basal | Number of Patients Requiring Naloxone for Respiratory Depression | 0 Participants |
| Intermittent Opioid on as Needed Basis | Number of Patients Requiring Naloxone for Respiratory Depression | 0 Participants |
Secondary
Parent Satisfaction With the Administration Technique
Parents were asked Overall, how satisfied were you with the pain relief your child received after surgery? Response options were: 1. Very Dissatisfied, 2. Dissatisfied, 3. Satisfied, 4. Very Satisfied. Responses were scored on a 1-4 scale, with Very Dissatisfied = 1; Dissatisfied = 2; Satisfied = 3; Very Satisfied = 4.
Time frame: parents, once at the end of study
Population: Data was obtained from parents who completed the satisfaction survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PNCA With Basal | Parent Satisfaction With the Administration Technique | 1.32 units on a scale | Standard Deviation 0.48 |
| PNCA Without Basal | Parent Satisfaction With the Administration Technique | 1.48 units on a scale | Standard Deviation 0.57 |
| Intermittent Opioid on as Needed Basis | Parent Satisfaction With the Administration Technique | 1.65 units on a scale | Standard Deviation 0.69 |