Trial Outcomes & Findings for Differences in Incidence of Common Side Effects Between Young Adults and Elderly Patients While Using IV-PCA (NCT NCT02448862)

NCT ID: NCT02448862

Last Updated: 2016-05-02

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 10575 participants
• Primary outcome timeframe: Postoperative 48 hours
• Results posted on: 2016-05-02

Participant Flow

Participant milestones

Measure	Elderly Patients 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.	Young Adults 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.
Overall Study STARTED	4525	6050
Overall Study COMPLETED	4525	6050
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Elderly Patients n=4525 Participants 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.	Young Adults n=6050 Participants 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 n=10575 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	6050 Participants n=7 Participants	6050 Participants n=5 Participants
Age, Categorical >=65 years	4525 Participants n=5 Participants	0 Participants n=7 Participants	4525 Participants n=5 Participants
Age, Continuous	74.8 years STANDARD_DEVIATION 4.4 • n=5 Participants	31.7 years STANDARD_DEVIATION 5.8 • n=7 Participants	57.8 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	2169 Participants n=5 Participants	3706 Participants n=7 Participants	5875 Participants n=5 Participants
Sex: Female, Male Male	2356 Participants n=5 Participants	2344 Participants n=7 Participants	4700 Participants n=5 Participants
Region of Enrollment Korea, Republic of	4525 participants n=5 Participants	6050 participants n=7 Participants	10575 participants n=5 Participants

PRIMARY outcome

Timeframe: Postoperative 48 hours

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

Outcome measures

Measure	Elderly Patients n=4525 Participants 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.	Young Adults n=6050 Participants 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.
Incidence of Rescue Analgesics Requirement	47.9 Percentage of Participants	53.8 Percentage of Participants

PRIMARY outcome

Timeframe: Postoperative 48 hours

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

Outcome measures

Measure	Elderly Patients n=4525 Participants 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.	Young Adults n=6050 Participants 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.
Incidence of Rescue Antiemetics Requirement	12.2 Percentage of Participants	10.1 Percentage of Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Elderly Patients n=4525 Participants 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.	Young Adults n=6050 Participants 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.
Postoperative Pain in Numeric Pain Scale Postoperative 0-6 hours	5.74 Scores on a scale Standard Deviation 1.90	5.70 Scores on a scale Standard Deviation 1.94
Postoperative Pain in Numeric Pain Scale Postoperative 6-12 hours	4.58 Scores on a scale Standard Deviation 1.8	4.68 Scores on a scale Standard Deviation 1.79
Postoperative Pain in Numeric Pain Scale Postoperative 12-18 hours	3.97 Scores on a scale Standard Deviation 1.63	3.91 Scores on a scale Standard Deviation 1.59
Postoperative Pain in Numeric Pain Scale Postoperative 18-24 hours	3.32 Scores on a scale Standard Deviation 1.46	3.33 Scores on a scale Standard Deviation 1.45
Postoperative Pain in Numeric Pain Scale Postoperative 24-48 hours	2.84 Scores on a scale Standard Deviation 1.32	2.83 Scores on a scale Standard Deviation 1.31

SECONDARY outcome

Timeframe: Postoperative 48 hours

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

Outcome measures

Measure	Elderly Patients n=4525 Participants 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.	Young Adults n=6050 Participants 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.
Incidence of Nausea and Vomiting	20.6 percentage of participants	23.8 percentage of participants

SECONDARY outcome

Timeframe: Postoperative 48 hours

The percentage of participants who had headache and dizziness

Outcome measures

Measure	Elderly Patients n=4525 Participants 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.	Young Adults n=6050 Participants 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.
Incidence of Dizziness or Headaches headache	1.7 percentage of participants	2.3 percentage of participants
Incidence of Dizziness or Headaches dizziness	6.5 percentage of participants	9.8 percentage of participants

Adverse Events

Elderly Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Young Adults

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jae Chul Koh, MD

Gangnam Severance hospital, Seoul, Korea

Phone: 82-01087023931

Email: aneskoh@yuhs.ac

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place