Laparotomy Clinical Trial
Official title:
A Randomized Controlled Trial on the Effect and Safety of Intravenous Nefopam/Fentanyl Postoperative Patient-Controlled-Analgesia in Patients Undergoing Laparotomy
Verified date | November 2015 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
BACKGROUND : There has been increasing interest on the use of nefopam in i.v.
patient-controlled analgesia (PCA).
OBJECTIVE : The aim of this study was to evaluate the opioid-sparing effect of nefopam, when
administered via i.v. PCA with fentanyl, after laparotomy. The adverse events associated
with its use were also evaluated, and specific considerations in its clinical use were
reviewed.
DESIGN : A randomized, controlled, single-centre, double-blinded study.
SETTING : One Korean university hospital.
PATIENTS : Seventy-one patients planned for elective open laparotomy
INTERVENTIONS : Patients were assigned into SF (control) or NF group, who received IV PCA
with fentanyl in normal saline (25 µg/ml), or a solution with 120 mg of nefopam included
(fentanyl 25 µg/ml and nefopam 1.2 mg/ml), respectively.
MAIN OUTCOME MEASURES : The pain intensity during the 24 h study period and patient
satisfaction at the end of the study were evaluated. Adverse events were observed.
Status | Completed |
Enrollment | 73 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - those planned for elective open laparotomy under general anesthesia, who were classified as ASA physical status I-II Exclusion Criteria: - the presence of renal and hepatic disease, high risk of urinary retention, seizure history, known allergy to any of the medications used, current history of psychiatric disorder, or those presently taking psychotropic medications or monoamine oxidase inhibitors. - Patients who could not understand verbal rating scale (VRS) and 11-points numeric rating scale (NRS) pain scores, or did not sign on informed consent |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Pharmbio Korea Co., Ltd. |
Oh CS, Jung E, Lee SJ, Kim SH. Effect of nefopam- versus fentanyl-based patient-controlled analgesia on postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery: a prospective double-blind randomized controlled trial. Curr Med Res Opin. 2015 Aug;31(8):1599-607. doi: 10.1185/03007995.2015.1058251. Epub 2015 Jul 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fentanyl consumption | during the stay at PACU, at the end of intervention (24h after surgery) | No | |
Secondary | pain intensity (NRS scores) | 1h, 2h, 6h, 12h and 24h postoperatively | No | |
Secondary | Satisfaction on analgesia using 4-points VRS (0: no satisfaction, 1: mild satisfaction, 2: moderate satisfaction, and 3: intense satisfaction) | at the end of the study (24 h after the surgery) | No | |
Secondary | hypertension, tachycardia, sweating, shivering, nausea, vomiting, sedation, pruritis and/or dry mouth | Throughout study on report-based (24h) | Yes | |
Secondary | hypertension, tachycardia | 1h, 2h, 6h, 12h and 24h postoperatively | Yes |
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