Pain, PostoperativeNCT02448862
Differences in Incidence of Common Side Effects Between Young Adults and Elderly Patients While Using IV-PCA
An observational study of Pain, Postoperative and Postoperative Nausea and Vomiting, run by Severance Hospital at 1 site in South Korea.
Trial summary
In this retrospective study, postoperative pain score, PCA-related complications, the risk factors for requirement of rescue analgesics and antiemetics will be evaluated in young and elderly patients, respectively, using fentanyl-based IV PCA during postoperative 48 hours after various surgeries. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain, Postoperative, Postoperative Nausea and Vomiting
- What is being tested?
- Fentanyl based IV-PCA
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 10,575 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to Aug 2015
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Collected data from the patients who had used IV-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and March. 2014.
Who may be able to join
- Patients who had used IV-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and March. 2014
Who cannot join
- Age < 20 years old,
- age 40 to 69,
- postoperative ventilator support or intensive care,
- and imperfect data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Incidence of Common Side Effects Between Young Adults and Elderly Patients While Using Fentanyl-based IV-PCA
In this retrospective study, postoperative pain score, PCA-related complications, the risk factors for requirement of rescue analgesics and antiemetics will be evaluated in young and elderly patients, respectively, using fentanyl-based IV PCA during postoperative 48 hours after various surgeries.
Read the detailed description
Since 2010, A PCA service team in the investigators' hospital have collected multidisciplinary clinical data from all the patients who used IV-PCA postoperatively in aim of the assessment of clinical outcome. The investigators reviewed the collected data from the patients who had used IV-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and March. 2014. The need for informed consent was waived for this study. The investigators have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs. Exclusion criteria were as following: age < 20 years old, age 40 to 69, postoperative ventilator support or intensive care, and imperfect data. The data of the PCA regimen which has been decided were recorded and analyzed. Demographic variables including age, sex, body mass index, American Society of Anesthesiologists (ASA) physical status and history of smoking, motion sickness, postoperative nausea/vomiting, hypertension and diabetes mellitus have been analyzed. Anesthesia and surgery-related variables including the duration of anesthesia, the type of anesthesia (general or spinal), laparoscopy and the operation site (categorized in abdominal, thoracic, upper \& lower extremities, head \& neck, spine and others) were also been analyzed. PCA-related variables included total dose of fentanyl for two days (µg/kg), use of mixed additional analgesics and antiemetics in PCA and discontinuation of PCA. When the patient requested the discontinuation of IV-PCA, the reason and the time have been recorded. Postoperative variables including the numeric rating scale (NRS, 0-10, 0 = no symptom; 10= unthinkable worst pain) for pain, requirements of rescue analgesics and antiemetics were analyzed. And the postoperative complications including nausea, vomiting, headache, dizziness, and sedation were analyzed. All the postoperative variables were recorded at postoperative 0-6 hrs including stay at post-anesthesia care unit, 6-12, 12-18, 18-24 and 24-48 hrs.
- Being tested
- Fentanyl based IV-PCA
- Keywords
- IV-PCA, Elderly patients, Yound adults, Side effect, Postoperative pain, Postoperative nausea and vomiting
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl based IV-PCADevice
Also called Intravenous patient controlled analgesic device
We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs.
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients | Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain. Receives: Device: Fentanyl based IV-PCA | |
| Young adults | Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain. Receives: Device: Fentanyl based IV-PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Rescue Analgesics Requirement
The percentage of patients who required rescue analgesics at least once during the postoperative 48-hour period
Measured: Postoperative 48 hours
Incidence of Rescue Antiemetics Requirement
The proportion of patients who required rescue antiemetics at least once during the postoperative 48-hour period
Measured: Postoperative 48 hours
Secondary outcomes (3)
Postoperative Pain in Numeric Pain Scale
The Numeric Pain Scale (NRS - 0: no pain, 10: worst pain can't imagine) for pain measured once at each time periods (0~6, 6~12, 12~18, 18~24, 24~48 hours)
Measured: Postoperative 48 hours
Incidence of Nausea and Vomiting
The percentage of participants who had nausea and vomiting during postoperative 48 hours
Measured: Postoperative 48 hours
Incidence of Dizziness or Headaches
The percentage of participants who had headache and dizziness
Measured: Postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionAug 2015
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 (2)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 10,575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Koh, Jae Chul, MD, Severance Hospital
- Investigators
- Jae Chul Koh, MD, Principal investigator, Gang Nam Severance Hospitial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448862
- Sponsor's protocol ID
- 2015-0098-001
- Status last verified
- Apr 2016
- First submitted
- 14 May 2015
- Last updated
- 2 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Choi JB, Shim YH, Lee YW, Lee JS, Choi JR, Chang CH. Incidence and risk factors of postoperative nausea and vomiting in patients with fentanyl-based intravenous patient-controlled analgesia and single antiemetic prophylaxis. Yonsei Med J. 2014 Sep;55(5):1430-5. doi: 10.3349/ymj.2014.55.5.1430.
PubMed 25048507Mortimer M, Ahlberg G; MUSIC-Norrtalje Study Group. To seek or not to seek? Care-seeking behaviour among people with low-back pain. Scand J Public Health. 2003;31(3):194-203. doi: 10.1080/14034940210134086.
PubMed 12850973
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Incidence of Common Side Effects Between Young Adults and Elderly Patients While Using Fentanyl-based IV-PCA
- ClinicalTrials.gov ID
- NCT02448862
- Acronym / sponsor ID
- 2015-0098-001
- Keywords
- IV-PCA, Elderly patients, Yound adults, Side effect, Postoperative pain, Postoperative nausea and vomiting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,575 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 May 2015 (estimated)
- Results
- Posted 2 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this retrospective study, postoperative pain score, PCA-related complications, the risk factors for requirement of rescue analgesics and antiemetics will be evaluated in young and elderly patients, respectively, using fentanyl-based IV PCA during postoperative 48 hours after various surgeries.
Detailed description
Since 2010, A PCA service team in the investigators' hospital have collected multidisciplinary clinical data from all the patients who used IV-PCA postoperatively in aim of the assessment of clinical outcome. The investigators reviewed the collected data from the patients who had used IV-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and March. 2014. The need for informed consent was waived for this study. The investigators have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs. Exclusion criteria were as following: age < 20 years old, age 40 to 69, postoperative ventilator support or intensive care, and imperfect data. The data of the PCA regimen which has been decided were recorded and analyzed. Demographic variables including age, sex, body mass index, American Society of Anesthesiologists (ASA) physical status and history of smoking, motion sickness, postoperative nausea/vomiting, hypertension and diabetes mellitus have been analyzed. Anesthesia and surgery-related variables including the duration of anesthesia, the type of anesthesia (general or spinal), laparoscopy and the operation site (categorized in abdominal, thoracic, upper \& lower extremities, head \& neck, spine and others) were also been analyzed. PCA-related variables included total dose of fentanyl for two days (µg/kg), use of mixed additional analgesics and antiemetics in PCA and discontinuation of PCA. When the patient requested the discontinuation of IV-PCA, the reason and the time have been recorded. Postoperative variables including the numeric rating scale (NRS, 0-10, 0 = no symptom; 10= unthinkable worst pain) for pain, requirements of rescue analgesics and antiemetics were analyzed. And the postoperative complications including nausea, vomiting, headache, dizziness, and sedation were analyzed. All the postoperative variables were recorded at postoperative 0-6 hrs including stay at post-anesthesia care unit, 6-12, 12-18, 18-24 and 24-48 hrs.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly patients | – | Device: Fentanyl based IV-PCAPatients aged over 70 who had used fentanyl based IV-PCA for postoperative pain. |
| Young adults | – | Device: Fentanyl based IV-PCAPatients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Collected data from the patients who had used IV-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and March. 2014.
Key inclusion criteria (1 listed)
- Patients who had used IV-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and March. 2014
Key exclusion criteria (4 listed)
- Age < 20 years old,
- age 40 to 69,
- postoperative ventilator support or intensive care,
- and imperfect data
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 |
|---|---|---|
| Fentanyl based IV-PCAAlso: Intravenous patient controlled analgesic deviceWe have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs. | Device | Elderly patients, Young adults |
Primary outcome
Incidence of Rescue Analgesics Requirement
Time frame: Postoperative 48 hours
The percentage of patients who required rescue analgesics at least once during the postoperative 48-hour period
Incidence of Rescue Antiemetics Requirement
Time frame: Postoperative 48 hours
The proportion of patients who required rescue antiemetics at least once during the postoperative 48-hour period
3 secondary outcomes
Postoperative Pain in Numeric Pain Scale
Time frame: Postoperative 48 hours
Incidence of Nausea and Vomiting
Time frame: Postoperative 48 hours
Incidence of Dizziness or Headaches
Time frame: Postoperative 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25048507Choi JB, Shim YH, Lee YW, Lee JS, Choi JR, Chang CH. Incidence and risk factors of postoperative nausea and vomiting in patients with fentanyl-based intravenous patient-controlled analgesia and single antiemetic prophylaxis. Yonsei Med J. 2014 Sep;55(5):1430-5. doi: 10.3349/ymj.2014.55.5.1430.
- Background: PubMed 12850973Mortimer M, Ahlberg G; MUSIC-Norrtalje Study Group. To seek or not to seek? Care-seeking behaviour among people with low-back pain. Scand J Public Health. 2003;31(3):194-203. doi: 10.1080/14034940210134086.
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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.
Jae Chul Koh, MD principal investigator
Gang Nam Severance Hospitial
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 Pain, Postoperative and Postoperative Nausea and Vomiting, run by Severance Hospital at 1 site in South Korea.
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 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 May 2016. 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 South Korea. 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 May 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?
Incidence of Rescue Analgesics Requirement (time frame: Postoperative 48 hours). The study lists 2 primary outcomes in all. 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 NCT02448862, which also lists 2 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 2 May 2016.