Abdominal SurgeryPNCANCT01823497
Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit
A study testing Morphine in people with Abdominal Surgery and Thoracic Surgery, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The aim of this study is to examine the safety and effectiveness of 2 morphine delivery systems for post-surgical neonates. The investigators hypothesize that this study will be feasible to conduct, and that neonates receiving morphine via a Parent/Nurse Controlled Analgesia pump will receive less morphine and… Read more about this study
- Who is it for?
- Ages 1 minute to 70 days
- Conditions the study is for
- Abdominal Surgery, Thoracic Surgery
- What is being tested?
- Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Mar 2019
- 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 1 minute to 70 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Surgery Location:
- Abdominal or Thoracic
- First surgery only
- Age:
- Born ≥ 34-44 weeks post-menstrual age
- Weight: Weight at birth or current weight ≥2 kg Intubated or extubated
Show all 11Show fewer
- Prior opioid exposure:
- < 2 days of continuous exposure
- if history of > 2 day continuous exposure, must be off continuous drip for a week
- Intermittent exposure ≤ 2 days prior to surgery Neonates exposed to chronic opioids in utero *In utero exposure to Selective Seretonin Reuptake Inhibitors and illicit drugs will be screened for and annotated.
- At least 1 parent is English-speaking
Who cannot join
- Surgery Type:
- Cardiac, Patent Ductus Arteriosus Ligation; Omphalocele (if intubated pre-operatively)
- Diagnoses:
- Necrotizing Enterocolitis; Diaphragmatic hernia (unless thoracoscopically repaired); Chemically or physiologically paralyzed Receiving vasopressors Receiving acetaminophen or a benzodiazepine (lorazepam or midazolam) ≤ 24 h before surgery Patients with any of the following: Epidural; Oscillating ventilator
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
About this study
Official title: Parent/Nurse Controlled Analgesia for Post-Operative Pain Management in Neonates: A Preliminary Randomized Controlled Trial
The aim of this study is to examine the safety and effectiveness of 2 morphine delivery systems for post-surgical neonates. The investigators hypothesize that this study will be feasible to conduct, and that neonates receiving morphine via a Parent/Nurse Controlled Analgesia pump will receive less morphine and experience fewer side effects than neonates receiving morphine via continuous opioid infusion.
- Conditions
- Abdominal Surgery, Thoracic Surgery
- Being tested
- Morphine
- Keywords
- Neonatal Intensive Care Unit, neonate, pain, morphine, Parent/Nurse Controlled Analgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Morphine will be used to control pain post-surgery.
| Study group | Role | What they receive |
|---|---|---|
| Parent/Nurse Controlled Analgesia | Active comparator | Parent/Nurse Controlled Analgesia will be the method of morphine delivery. Receives: Drug: Morphine |
| Continuous Opioid Infusion | Active comparator | Continuous Opioid Infusion will be the method used to deliver morphine to group 2 Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Consumption
The investigators will measure amount of morphine consumed post-surgery in mg/kg/hour
Measured: 5 days post surgery
Secondary outcomes (1)
Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale
The investigators will report the average pain score per POD, for 4 days (PODs 0,1,2,3). Higher scores mean worse outcome. Good pain control will be defined as pain less than 4 on a 0-10 scale. Pain is scored by observers on a minimum of 0 (no pain) to a maximum of 10 (worst pain) on this scale. The median and inter-quartile range of the average pain score per post-operative day is reported. The timeframe includes the post-operative day (POD 0), and 3 days post-surgery (POD 1-3), for a total of 4 post-operative days.
Measured: 4 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2019
- Study completionMar 2019
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.
- Other trials for Abdominal SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- Sponsor
- Investigators
- Keri R Hainsworth, PhD, Principal investigator, Medical College of WisconsinMichelle L Czarnecki, MSN RN-BC CPNP, Principal investigator, Children's Hospital and Health System Foundation, Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823497
- Sponsor's protocol ID
- FP4155
- Acronym
- PNCA
- Status last verified
- Aug 2020
- First submitted
- 29 Mar 2013
- Last updated
- 2 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent/Nurse Controlled Analgesia for Post-Operative Pain Management in Neonates: A Preliminary Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01823497
- Acronym / sponsor ID
- PNCA / FP4155
- Conditions
- Abdominal Surgery, Thoracic Surgery
- Keywords
- Neonatal Intensive Care Unit, neonate, pain, morphine, Parent/Nurse Controlled Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Study start
- Apr 2013 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 2 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to examine the safety and effectiveness of 2 morphine delivery systems for post-surgical neonates. The investigators hypothesize that this study will be feasible to conduct, and that neonates receiving morphine via a Parent/Nurse Controlled Analgesia pump will receive less morphine and experience fewer side effects than neonates receiving morphine via continuous opioid infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent/Nurse Controlled Analgesia | Active comparator | Drug: MorphineParent/Nurse Controlled Analgesia will be the method of morphine delivery. |
| Continuous Opioid Infusion | Active comparator | Drug: MorphineContinuous Opioid Infusion will be the method used to deliver morphine to group 2 |
Who may qualify
- Ages
- 1 minute to 70 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Surgery Location:
- Born ≥ 34-44 weeks post-menstrual age
- Weight: Weight at birth or current weight ≥2 kg Intubated or extubated
- < 2 days of continuous exposure
- if history of > 2 day continuous exposure, must be off continuous drip for a week
Key exclusion criteria (4 listed)
- Surgery Type:
- Necrotizing Enterocolitis; Diaphragmatic hernia (unless thoracoscopically repaired); Chemically or physiologically paralyzed Receiving vasopressors Receiving acetaminophen or a benzodiazepine (lorazepam or midazolam) ≤ 24 h before surgery Patients with any of the following: Epidural; Oscillating 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 |
|---|---|---|
| MorphineMorphine will be used to control pain post-surgery. | Drug | Continuous Opioid Infusion, Parent/Nurse Controlled Analgesia |
Primary outcome
Morphine Consumption
Time frame: 5 days post surgery
The investigators will measure amount of morphine consumed post-surgery in mg/kg/hour
1 secondary outcome
Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale
Time frame: 4 days post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Keri R Hainsworth, PhD principal investigator
Medical College of Wisconsin
Michelle L Czarnecki, MSN RN-BC CPNP principal investigator
Children's Hospital and Health System Foundation, 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 Morphine in people with Abdominal Surgery and Thoracic Surgery, 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 11 inclusion and 4 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 2 Sep 2020. 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 2 Sep 2020). 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?
Morphine Consumption (time frame: 5 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2020.