Post Operative PainPNCANCT00743730
Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay
A study testing Pain and standard side effect management for PNCA with basal method., Pain and standard side effect management with PNCA without basal and Pain and standard side effect management with IV on an as needed basis method. in people with Post Operative Pain, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Pain and standard side effect management for PNCA with basal method., Pain and standard side effect management with PNCA without basal and Pain and standard side effect management with IV on an as needed basis method.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Feb 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Outcomes And Parent Satisfaction Associated With Parent/Nurse Controlled Analgesia In Pediatric Patients With Developmental Delay
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.
Read the 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:
- Parent/Nurse controlled Analgesia (PNCA) with a continuous intravenous (IV)infusion of pain medicine.
- PNCA without continuous IV infusion of pain medicine.
- 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.
- Conditions
- Post Operative Pain
- Being tested
- Pain and standard side effect management for PNCA with basal method., Pain and standard side effect management with PNCA without basal, Pain and standard side effect management with IV on an as needed basis method.
- 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
- Medical subject headings
- Pain, Postoperative, Learning Disabilities, Cognitive Dysfunction, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain and standard side effect management for PNCA with basal method.Other
Also called PNCA with basal
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.
Pain and standard side effect management with PNCA without basalOther
Also called 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.
Pain and standard side effect management with IV on an as needed basis method.Other
Also called morphine injection, pain medication administered by IV as needed
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.
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Parent and Nurse Controlled Analgesics with basal Receives: Other: Pain and standard side effect management for PNCA with basal method. |
| II | Active comparator | Parent and Nurse Controlled Analgesics without basal Receives: Other: Pain and standard side effect management with PNCA without basal |
| III | Active comparator | Intermittent opioid administered IV on an "as needed" basis Receives: Other: Pain and standard side effect management with IV on an as needed basis method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 24 hours on study
Secondary outcomes (2)
Number of Patients Requiring Naloxone for Respiratory Depression
Number of patients requiring naloxone for respiratory depression (our most important side effect)
Measured: Daily, for up to 3 days
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.
Measured: parents, once at the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startJun 2005
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Responsible party
- Principal investigator, Michelle Czarnecki, Medical College of Wisconsin
- Investigators
- Michelle Czarnecki, MSN RN CPNP, Principal investigator, Childrens Hospital of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743730
- Sponsor's protocol ID
- CHW 05/02, HRRC 008-05
- Acronym
- PNCA
- Status last verified
- Aug 2019
- First submitted
- 12 Jun 2008
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Doyle E, Harper I, Morton NS. Patient-controlled analgesia with low dose background infusions after lower abdominal surgery in children. Br J Anaesth. 1993 Dec;71(6):818-22. doi: 10.1093/bja/71.6.818.
PubMed 8280546Doyle E, Robinson D, Morton NS. Comparison of patient-controlled analgesia with and without a background infusion after lower abdominal surgery in children. Br J Anaesth. 1993 Nov;71(5):670-3. doi: 10.1093/bja/71.5.670.
PubMed 8251277Foster RL, Varni JW. Measuring the quality of children's postoperative pain management: initial validation of the child/parent Total Quality Pain Management (TQPM) instruments. J Pain Symptom Manage. 2002 Mar;23(3):201-10. doi: 10.1016/s0885-3924(01)00411-0.
PubMed 11888718Gaukroger PB, Tomkins DP, van der Walt JH. Patient-controlled analgesia in children. Anaesth Intensive Care. 1989 Aug;17(3):264-8. doi: 10.1177/0310057X8901700304.
PubMed 2774144Gureno MA, Reisinger CL. Patient controlled analgesia for the young pediatric patient. Pediatr Nurs. 1991 May-Jun;17(3):251-4.
PubMed 2062584Kotzer AM, Foster R. Children's use of PCA following spinal fusion. Orthop Nurs. 2000 Sep-Oct;19(5):19-27; quiz 28-30. doi: 10.1097/00006416-200019050-00005.
PubMed 11153382Malviya S, Voepel-Lewis T, Tait AR, Merkel S, Lauer A, Munro H, Farley F. Pain management in children with and without cognitive impairment following spine fusion surgery. Paediatr Anaesth. 2001 Jul;11(4):453-8. doi: 10.1046/j.1460-9592.2001.00686.x.
PubMed 11442864McGrath PJ, Rosmus C, Canfield C, Campbell MA, Hennigar A. Behaviours caregivers use to determine pain in non-verbal, cognitively impaired individuals. Dev Med Child Neurol. 1998 May;40(5):340-3.
PubMed 9630262McNeely JK, Trentadue NC. Comparison of patient-controlled analgesia with and without nighttime morphine infusion following lower extremity surgery in children. J Pain Symptom Manage. 1997 May;13(5):268-73. doi: 10.1016/s0885-3924(96)00324-7.
PubMed 9185432Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
PubMed 9220806Miaskowski C, Crews J, Ready LB, Paul SM, Ginsberg B. Anesthesia-based pain services improve the quality of postoperative pain management. Pain. 1999 Mar;80(1-2):23-9. doi: 10.1016/s0304-3959(98)00192-4.
PubMed 10204714Oberlander TF, Gilbert CA, Chambers CT, O'Donnell ME, Craig KD. Biobehavioral responses to acute pain in adolescents with a significant neurologic impairment. Clin J Pain. 1999 Sep;15(3):201-9. doi: 10.1097/00002508-199909000-00007.
PubMed 10524473Pellino TA, Ward SE. Perceived control mediates the relationship between pain severity and patient satisfaction. J Pain Symptom Manage. 1998 Feb;15(2):110-6.
PubMed 9494309Peters JW, Bandell Hoekstra IE, Huijer Abu-Saad H, Bouwmeester J, Meursing AE, Tibboel D. Patient controlled analgesia in children and adolescents: a randomized controlled trial. Paediatr Anaesth. 1999;9(3):235-41. doi: 10.1046/j.1460-9592.1999.00358.x.
PubMed 10320603Rodgers BM, Webb CJ, Stergios D, Newman BM. Patient-controlled analgesia in pediatric surgery. J Pediatr Surg. 1988 Mar;23(3):259-62. doi: 10.1016/s0022-3468(88)80735-8.
PubMed 3357143
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes And Parent Satisfaction Associated With Parent/Nurse Controlled Analgesia In Pediatric Patients With Developmental Delay
- ClinicalTrials.gov ID
- NCT00743730
- Acronym / sponsor ID
- PNCA / CHW 05/02, HRRC 008-05
- Conditions
- Post Operative Pain
- Keywords
- developmental delay, cognitive impairment, pain control, post operative pain, opioid, pain assessment, Parent Nurse controlled Analgesic, patient controlled analgesic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Study start
- Jun 2005
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Posted 15 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Parent/Nurse controlled Analgesia (PNCA) with a continuous intravenous (IV)infusion of pain medicine.
- PNCA without continuous IV infusion of pain medicine.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Other: Pain and standard side effect management for PNCA with basal method.Parent and Nurse Controlled Analgesics with basal |
| II | Active comparator | Other: Pain and standard side effect management with PNCA without basalParent and Nurse Controlled Analgesics without basal |
| III | Active comparator | Other: Pain and standard side effect management with IV on an as needed basis method.Intermittent opioid administered IV on an "as needed" basis |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain and standard side effect management for PNCA with basal method.Also: PNCA with basalComparing 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. | Other | I |
| Pain and standard side effect management with PNCA without basalAlso: PNCA without basalComparing 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. | Other | II |
| Pain and standard side effect management with IV on an as needed basis method.Also: morphine injection, pain medication administered by IV as neededComparing 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. | Other | III |
Primary outcome
Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale
Time frame: 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.
2 secondary outcomes
Number of Patients Requiring Naloxone for Respiratory Depression
Time frame: Daily, for up to 3 days
Parent Satisfaction With the Administration Technique
Time frame: parents, once at the end of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8280546Doyle E, Harper I, Morton NS. Patient-controlled analgesia with low dose background infusions after lower abdominal surgery in children. Br J Anaesth. 1993 Dec;71(6):818-22. doi: 10.1093/bja/71.6.818.
- Background: PubMed 8251277Doyle E, Robinson D, Morton NS. Comparison of patient-controlled analgesia with and without a background infusion after lower abdominal surgery in children. Br J Anaesth. 1993 Nov;71(5):670-3. doi: 10.1093/bja/71.5.670.
- Background: PubMed 11888718Foster RL, Varni JW. Measuring the quality of children's postoperative pain management: initial validation of the child/parent Total Quality Pain Management (TQPM) instruments. J Pain Symptom Manage. 2002 Mar;23(3):201-10. doi: 10.1016/s0885-3924(01)00411-0.
- Background: PubMed 2774144Gaukroger PB, Tomkins DP, van der Walt JH. Patient-controlled analgesia in children. Anaesth Intensive Care. 1989 Aug;17(3):264-8. doi: 10.1177/0310057X8901700304.
- Background: PubMed 2062584Gureno MA, Reisinger CL. Patient controlled analgesia for the young pediatric patient. Pediatr Nurs. 1991 May-Jun;17(3):251-4.
- Background: PubMed 11153382Kotzer AM, Foster R. Children's use of PCA following spinal fusion. Orthop Nurs. 2000 Sep-Oct;19(5):19-27; quiz 28-30. doi: 10.1097/00006416-200019050-00005.
- Background: PubMed 11442864Malviya S, Voepel-Lewis T, Tait AR, Merkel S, Lauer A, Munro H, Farley F. Pain management in children with and without cognitive impairment following spine fusion surgery. Paediatr Anaesth. 2001 Jul;11(4):453-8. doi: 10.1046/j.1460-9592.2001.00686.x.
- Background: PubMed 9630262McGrath PJ, Rosmus C, Canfield C, Campbell MA, Hennigar A. Behaviours caregivers use to determine pain in non-verbal, cognitively impaired individuals. Dev Med Child Neurol. 1998 May;40(5):340-3.
- Background: PubMed 9185432McNeely JK, Trentadue NC. Comparison of patient-controlled analgesia with and without nighttime morphine infusion following lower extremity surgery in children. J Pain Symptom Manage. 1997 May;13(5):268-73. doi: 10.1016/s0885-3924(96)00324-7.
- Background: PubMed 9220806Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
- Background: PubMed 10204714Miaskowski C, Crews J, Ready LB, Paul SM, Ginsberg B. Anesthesia-based pain services improve the quality of postoperative pain management. Pain. 1999 Mar;80(1-2):23-9. doi: 10.1016/s0304-3959(98)00192-4.
- Background: PubMed 10524473Oberlander TF, Gilbert CA, Chambers CT, O'Donnell ME, Craig KD. Biobehavioral responses to acute pain in adolescents with a significant neurologic impairment. Clin J Pain. 1999 Sep;15(3):201-9. doi: 10.1097/00002508-199909000-00007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Czarnecki, MSN RN CPNP principal investigator
Childrens Hospital of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain and standard side effect management for PNCA with basal method., Pain and standard side effect management with PNCA without basal and Pain and standard side effect management with IV on an as needed basis method. in people with Post Operative Pain, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale (time frame: First 24 hours on study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00743730, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.