Postoperative Pain ManagementNCT01378663
Review of Pain Management After Congenital Cardiac Surgery
An observational study of Postoperative Pain Management, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
One of the main problems that faces children undergoing congenital cardiac surgery is posoperative pain management. PCAs (Patient Controlled Analgesia) and NCAs (Nurse Controlled Analgesia) are the main means of pain management here at NCH. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain Management
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA.
Who may be able to join
- All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA.
Who cannot join
- All patients that underwent congenital cardiac surgery from 2004 till 2010 and did not receive PCA or NCA for postoperative pain management.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
One of the main problems that faces children undergoing congenital cardiac surgery is posoperative pain management. PCAs (Patient Controlled Analgesia) and NCAs (Nurse Controlled Analgesia) are the main means of pain management here at NCH. In this study, the investigators will review the difference between different PCA and NCA modalities. Also, the investigators aim to find out if there are differences between age groups in terms of type of drug used, total drug used, side effects and length of use of the PCA or NCA.
Read the detailed description
All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA will be included. Data will be collected from the pain team database and charts review. Data will include; patient's age, weight, sex, procedure, pain scores and sedation score during the times of PCA and NCA use, side effects (respiratory depression, nausea, vomitting, pruritus, itching and other).In addition we will record the total days of PCA and NCA use. We will also look at the incidence of changes done in the PCA/NCA and drug itself.
Identifying the ideal drug and dose based on the patient's age and procedure will allow us to take better care of our patients. Our patient population is peculiar in the fact that a big percentage of our patients are extubated in the Operating Room. For this reason, sedation and analgesia play an important role for our continued success in taking care of them.
- Conditions
- Postoperative Pain Management
- Keywords
- Congenital cardiac surgery, Postoperative pain management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post congenital cardiac surgery pain management | All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain ManagementStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aymen N Naguib, Nationwide Children's Hospital
- Investigators
- Aymen N Naguib, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378663
- Sponsor's protocol ID
- IRB10-00058
- Status last verified
- Mar 2012
- First submitted
- 21 Jun 2011
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Howard RF, Lloyd-Thomas A, Thomas M, Williams DG, Saul R, Bruce E, Peters J. Nurse-controlled analgesia (NCA) following major surgery in 10,000 patients in a children's hospital. Paediatr Anaesth. 2010 Feb;20(2):126-34. doi: 10.1111/j.1460-9592.2009.03242.x.
PubMed 20078810
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Review of Pain Management After Congenital Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01378663
- Acronym / sponsor ID
- IRB10-00058
- Conditions
- Postoperative Pain Management
- Keywords
- Congenital cardiac surgery, Postoperative pain management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the main problems that faces children undergoing congenital cardiac surgery is posoperative pain management. PCAs (Patient Controlled Analgesia) and NCAs (Nurse Controlled Analgesia) are the main means of pain management here at NCH. In this study, the investigators will review the difference between different PCA and NCA modalities. Also, the investigators aim to find out if there are differences between age groups in terms of type of drug used, total drug used, side effects and length of use of the PCA or NCA.
Detailed description
All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA will be included. Data will be collected from the pain team database and charts review. Data will include; patient's age, weight, sex, procedure, pain scores and sedation score during the times of PCA and NCA use, side effects (respiratory depression, nausea, vomitting, pruritus, itching and other).In addition we will record the total days of PCA and NCA use. We will also look at the incidence of changes done in the PCA/NCA and drug itself.
Identifying the ideal drug and dose based on the patient's age and procedure will allow us to take better care of our patients. Our patient population is peculiar in the fact that a big percentage of our patients are extubated in the Operating Room. For this reason, sedation and analgesia play an important role for our continued success in taking care of them.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post congenital cardiac surgery pain management | – | –All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA.
Key inclusion criteria (1 listed)
- All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA.
Key exclusion criteria (1 listed)
- All patients that underwent congenital cardiac surgery from 2004 till 2010 and did not receive PCA or NCA for postoperative pain management.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
- Background: PubMed 20078810Howard RF, Lloyd-Thomas A, Thomas M, Williams DG, Saul R, Bruce E, Peters J. Nurse-controlled analgesia (NCA) following major surgery in 10,000 patients in a children's hospital. Paediatr Anaesth. 2010 Feb;20(2):126-34. doi: 10.1111/j.1460-9592.2009.03242.x.
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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.
Aymen N Naguib, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain Management, run by Nationwide Children's Hospital 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 1 inclusion and 1 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 20 Mar 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01378663, which also lists 1 linked publication.
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 20 Mar 2012.