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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02448862

Enrollment

10575

Registered

2015-05-20

Start date

2015-05-31

Completion date

2015-08-31

Last updated

2016-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Postoperative Nausea and Vomiting

Keywords

IV-PCA, Elderly patients, Yound adults, Side effect, Postoperative pain, Postoperative nausea and vomiting

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.

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.

Interventions

DEVICEFentanyl 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.

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Measure	Time frame	Description
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)
Incidence of Nausea and Vomiting	Postoperative 48 hours	The percentage of participants who had nausea and vomiting during postoperative 48 hours
Incidence of Dizziness or Headaches	Postoperative 48 hours	The percentage of participants who had headache and dizziness

Countries

South Korea

Participant flow

Participants by arm

Arm	Count
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.	4,525
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.	6,050
Total	10,575

Baseline characteristics

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

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 4,525	0 / 6,050
serious Total, serious adverse events	0 / 4,525	0 / 6,050

Outcome results

Primary

Incidence of Rescue Analgesics Requirement

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