Differences in Incidence of Common Side Effects Between Young Adults and Elderly Patients While Using IV-PCA

Pain, Postoperative Clinical Trial

Official title:

Differences in Incidence of Common Side Effects Between Young Adults and Elderly Patients While Using Fentanyl-based IV-PCA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02448862
• Other study ID #: 2015-0098-001
• Status: Recruiting
• Phase: N/A
• First received: May 14, 2015
• Last updated: May 19, 2015
• Start date: May 2015
• Est. completion date: July 2015

Study information

• Verified date: May 2015
• Source: Severance Hospital
• Contact: Jae Chul Koh, MD
• Phone: 82-010-8702-3931
• Email: aneskoh[@]yuhs.ac
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who had used IV-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and March. 2014

Exclusion Criteria:

• Age < 20 years old,

• age 40 to 69,

• postoperative ventilator support or intensive care,

• and imperfect data

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Nausea and Vomiting

Intervention

Device:
• Fentanyl based IV-PCA
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.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance hospital	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

Mortimer M, Ahlberg G; MUSIC-Norrtälje 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of rescue analgesics requirement		Postoperative 72 hours	No
Primary	Incidence of rescue antiemetics requirement		Postoperative 72 hours	No
Secondary	Postoperative pain in VAS		Postoperative 72 hours	No
Secondary	Incidence of nausea and vomiting		Postoperative 72 hours	No
Secondary	Incidence of dizziness or headaches		Postoperative 72 hours	No