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

• Sponsor: Severance Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02448862
• Collaborator: (none)
• Enrollment: 10,575
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 3498.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative; Postoperative Nausea and Vomiting	Device: Fentanyl based IV-PCA

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

• Study Type: Observational
• Actual Enrollment: 10575 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Differences in Incidence of Common Side Effects Between Young Adults and Elderly Patients While Using Fentanyl-based IV-PCA
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Elderly patients Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.	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.; Other Names: Intravenous patient controlled analgesic device
Young adults Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.	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.; Other Names: Intravenous patient controlled analgesic device

Outcome Measures

Primary Outcome Measures

1. Incidence of Rescue Analgesics Requirement [Postoperative 48 hours]

   The percentage of patients who required rescue analgesics at least once during the postoperative 48-hour period

2. Incidence of Rescue Antiemetics Requirement [Postoperative 48 hours]

   The proportion of patients who required rescue antiemetics at least once during the postoperative 48-hour period

Secondary Outcome Measures

1. Postoperative Pain in Numeric Pain Scale [Postoperative 48 hours]

   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)

2. Incidence of Nausea and Vomiting [Postoperative 48 hours]

   The percentage of participants who had nausea and vomiting during postoperative 48 hours

3. Incidence of Dizziness or Headaches [Postoperative 48 hours]

   The percentage of participants who had headache and dizziness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangnam Severance hospital	Seoul	Gangnam-gu	Korea, Republic of	135-720

Sponsors and Collaborators

• Severance Hospital

Investigators

• Principal Investigator: Jae Chul Koh, MD, Gang Nam Severance Hospitial

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.

• Responsible Party: Dr. Koh, Jae Chul, MD, Department of anesthesiology and pain medicine, Severance Hospital
• ClinicalTrials.gov Identifier: NCT02448862
• Other Study ID Numbers: 2015-0098-001
• First Posted: May 20, 2015
• Last Update Posted: May 2, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Dr. Koh, Jae Chul, MD, Department of anesthesiology and pain medicine, Severance Hospital: IV-PCA; Elderly patients; Yound adults; Side effect; Postoperative pain; Postoperative nausea and vomiting
• Additional relevant MeSH terms: Nausea; Vomiting; Pain, Postoperative; Postoperative Nausea and Vomiting; Fentanyl; Analgesics

Study Results

Participant Flow

Arm/Group Title	Elderly Patients	Young Adults
Arm/Group Description	Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain. 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.	Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain. 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.
Period Title: Overall Study
STARTED	4525	6050
COMPLETED	4525	6050
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Elderly Patients	Young Adults	Total
Arm/Group Description	Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain. 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.	Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain. 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.	Total of all reporting groups
Overall Participants	4525	6050	10575
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	6050 100%	6050 57.2%
>=65 years	4525 100%	0 0%	4525 42.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.8 (4.4)	31.7 (5.8)	57.8 (5.2)
Sex: Female, Male (Count of Participants)
Female	2169 47.9%	3706 61.3%	5875 55.6%
Male	2356 52.1%	2344 38.7%	4700 44.4%
Region of Enrollment (participants) [Number]
Korea, Republic of	4525 100%	6050 100%	10575 100%

Outcome Measures

1. Primary Outcome

Title	Incidence of Rescue Analgesics Requirement
Description	The percentage of patients who required rescue analgesics at least once during the postoperative 48-hour period
Time Frame	Postoperative 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Elderly Patients	Young Adults
Arm/Group Description	Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain. 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.	Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain. 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.
Measure Participants	4525	6050
Number [Percentage of Participants]	47.9 1.1%	53.8 0.9%

2. Primary Outcome

Title	Incidence of Rescue Antiemetics Requirement
Description	The proportion of patients who required rescue antiemetics at least once during the postoperative 48-hour period
Time Frame	Postoperative 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Elderly Patients	Young Adults
Arm/Group Description	Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain. 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.	Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain. 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.
Measure Participants	4525	6050
Number [Percentage of Participants]	12.2 0.3%	10.1 0.2%

3. Secondary Outcome

Title	Postoperative Pain in Numeric Pain Scale
Description	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)
Time Frame	Postoperative 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Elderly Patients	Young Adults
Arm/Group Description	Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain. 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.	Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain. 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.
Measure Participants	4525	6050
Postoperative 0-6 hours	5.74 (1.90)	5.70 (1.94)
Postoperative 6-12 hours	4.58 (1.8)	4.68 (1.79)
Postoperative 12-18 hours	3.97 (1.63)	3.91 (1.59)
Postoperative 18-24 hours	3.32 (1.46)	3.33 (1.45)
Postoperative 24-48 hours	2.84 (1.32)	2.83 (1.31)

4. Secondary Outcome

Title	Incidence of Nausea and Vomiting
Description	The percentage of participants who had nausea and vomiting during postoperative 48 hours
Time Frame	Postoperative 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Elderly Patients	Young Adults
Arm/Group Description	Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain. 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.	Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain. 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.
Measure Participants	4525	6050
Number [percentage of participants]	20.6 0.5%	23.8 0.4%

5. Secondary Outcome

Title	Incidence of Dizziness or Headaches
Description	The percentage of participants who had headache and dizziness
Time Frame	Postoperative 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Elderly Patients	Young Adults
Arm/Group Description	Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain. 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.	Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain. 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.
Measure Participants	4525	6050
headache	1.7 0%	2.3 0%
dizziness	6.5 0.1%	9.8 0.2%

Adverse Events

Arm/Group Title	Elderly Patients		Young Adults
Arm/Group Description	Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain. 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.		Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain. 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.
All Cause Mortality
	Elderly Patients		Young Adults
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Elderly Patients		Young Adults
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4525 (0%)		0/6050 (0%)
Other (Not Including Serious) Adverse Events
	Elderly Patients		Young Adults
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4525 (0%)		0/6050 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.