N/A
N=180
Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Hyperalgesia Induced by Remifentanil in Patients
Pain · Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT02043366 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm — 60.57; 78.29; 68.50; 79.7 g
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Normal Saline (Drug); Butorphanol (Drug); Flurbiprofen axetil (Drug); Remifentanil (Drug); Sufentanil (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tianjin Medical University General Hospital
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm |
60.57; 78.29; 68.50; 79.7; 81.64; 89.5 | — |
| SECONDARY Pain Score (NRS) |
— | — |
| SECONDARY Time of First Postoperative Analgesic Requirement |
— | — |
| SECONDARY Occurrence of Side Effects |
— | — |
| SECONDARY Total Dose of First Postoperative Analgesic Requirement |
— | — |
| SECONDARY Cumulative Sufentanyl Consumption |
— | — |
| SECONDARY Normalized Area of Hyperalgesia Around the Incision |
60.46; 53.64; 56.57; 54.00; 52.5; 49.89 | — |
Summary
Purpose:
To explore and compare antihyperalgesic effects of butorphanol, flurbiprofen axetil, and a combination of both received before anesthesia induction.
To evaluate and examine the incidence of adverse effects with the purpose of selecting the optimum dose.
.
Eligibility Criteria
Inclusion Criteria
- Subject is scheduled to undergo lower abdominal surgery under a short general anesthesia of less than 2 hours
- Subject's American Society of Anesthesiologists physical status is I-II.
- The subject's parent/legally authorized guardian has given written informed consent to participate.
Exclusion Criteria
- Subject has a diagnosis of renal or liver failure.
- Subject has a diagnosis of Insulin dependent diabetes.
- Subject is allergy and contraindication to butorphanol or NSAIDs.
- Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
- Subject has any contraindication for the use of patient-controlled analgesia (PCA).
- Subject is pregnant or breast-feeding.
- Subject is obese (body mass index >30kg/m^2).
Data sourced from ClinicalTrials.gov (NCT02043366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.