N/A Completed N=180 Randomized Double-blind Prevention

Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Hyperalgesia Induced by Remifentanil in Patients

Postoperative Pain · Anesthesia

Source: ClinicalTrials.gov NCT02043366 ↗

Enrolled (actual)

180

Serious AEs

0.0%

Results posted

Sep 2015

Primary outcomePrimary: Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm — 60.57; 78.29; 68.50; 79.7 g

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. .

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	—

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).

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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. Informational only — not medical advice.