Trial Outcomes & Findings for Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay (NCT NCT00743730)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

94 participants

Primary outcome timeframe

First 24 hours on study

Results posted on

2019-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	Medication as Needed 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.
Overall Study STARTED	27	34	33
Overall Study COMPLETED	22	30	28
Overall Study NOT COMPLETED	5	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	I PNCA With Basal n=22 Participants 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.	II PNCA w/o Basal n=30 Participants 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.	III PRN Intermittent n=28 Participants 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.	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	80 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	10.5 years n=5 Participants	12 years n=7 Participants	12 years n=5 Participants	12 years n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	15 Participants n=7 Participants	11 Participants n=5 Participants	34 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	17 Participants n=5 Participants	46 Participants n=4 Participants
Region of Enrollment United States	22 participants n=5 Participants	30 participants n=7 Participants	28 participants n=5 Participants	80 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PNCA With Basal n=22 Participants 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.	PNCA Without Basal n=30 Participants 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.	Intermittent Opioid on as Needed Basis n=28 Participants 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.
Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale	1.0 units on a scale Interval 0.4 to 1.7	1.8 units on a scale Interval 0.2 to 3.0	1.5 units on a scale Interval 0.5 to 2.3

SECONDARY outcome

Timeframe: Daily, for up to 3 days

Number of patients requiring naloxone for respiratory depression (our most important side effect)

Outcome measures

Outcome measures
Measure	PNCA With Basal n=22 Participants 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.	PNCA Without Basal n=30 Participants 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.	Intermittent Opioid on as Needed Basis n=28 Participants 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.
Number of Patients Requiring Naloxone for Respiratory Depression	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: parents, once at the end of study

Population: Data was obtained from parents who completed the satisfaction survey

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.

Outcome measures

Outcome measures
Measure	PNCA With Basal n=21 Participants 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.	PNCA Without Basal n=28 Participants 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.	Intermittent Opioid on as Needed Basis n=26 Participants 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.
Parent Satisfaction With the Administration Technique	1.32 units on a scale Standard Deviation 0.48	1.48 units on a scale Standard Deviation 0.57	1.65 units on a scale Standard Deviation 0.69

Adverse Events

I PNCA With Basal

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

II PNCA w/o Basal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

III PRN Intermittent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	I PNCA With Basal n=27 participants at risk 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.	II PNCA w/o Basal n=34 participants at risk 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.	III PRN Intermittent n=33 participants at risk 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.
Respiratory, thoracic and mediastinal disorders respiratory depression	3.7% 1/27 • Number of events 1	0.00% 0/34	0.00% 0/33

Other adverse events

Adverse event data not reported

Additional Information

Keri R. Hainsworth, PhD, Research Director

Medical College of Wisconsin

Phone: 414-266-6306

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place