Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide.
Tammy C Hoffmann, Paul P Glasziou, Isabelle Boutron...
https://pubmed.ncbi.nlm.nih.gov/24609605Actively Recruiting
Led by Universidad de Antioquia · Updated on 2025-04-11
120
Participants Needed
1
Research Sites
63 weeks
Total Duration
U
Universidad de Antioquia
Lead Sponsor
H
Hospital San Vicente Fundación
Collaborating Sponsor
Researchers are evaluating how to best manage pain after major orthopedic surgery in adults. This clinical trial compares two ways of giving ketamine, a pain-relieving medicine: a continuous intravenous infusion versus a patient-controlled analgesia (PCA) pump. The study aims to see if continuous infusion is as effective as PCA for pain control and if it reduces the need for opioid pain medicines within the first 24 hours after surgery. Participants will be randomly assigned to one of two groups. One group receives ketamine through a continuous infusion starting at surgical closure, with specific dosing for 48 hours. The other group uses a PCA pump delivering a mix of ketamine and morphine, allowing patients to control their doses with limits set by the pump for up to 48 hours. Both groups have access to rescue morphine via PCA if needed. The trial is designed to be triple-blind, ensuring unbiased results. During the first three days after surgery, researchers will visit participants in the hospital to assess pain levels and monitor side effects. Various outcomes will be measured, including pain at rest and with movement, opioid use, time to walking, length of hospital stay, nausea, sedation, delirium, and vital signs. Participants may be followed for up to 36 months to assess long-term outcomes such as hospital stay duration and recovery. The total treatment and observation period is focused on the initial 72 hours after surgery.
CONDITIONS
Analgesic Efficacy of Intravenous Ketamine as a Continuous Infusion vs PCA in the Management of Acute Postoperative Pain in Major Orthopedic Surgery.
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 hours postoperatively
Participants receive intravenous ketamine by either continuous infusion or patient-controlled analgesia (PCA) for pain management after major orthopedic surgery.
Continuous monitoring during hospital stay for up to 48 hours
Duration - Up to 72 hours after surgery
Participants are monitored for pain control, opioid use, and potential side effects up to 72 hours after surgery.
Assessments at 12, 24, 48, and 72 hours after surgery
Total: 1 location
1
St. Vincent's Foundation University Hospital
Medellín, Antioquia, Colombia, 050010
Actively Recruiting
F
Fabian D Casas, Professor
M
Mateo Aristizabal, Resident
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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