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Comparison the effect of the intravenous ketamine versus lidocaine in decreasing severity of pain in opioid addicted patients undergoing orthopedic surgeries.

Comparison the effect of intraoperative ketamine and systemic lidocaine on post operative pain management of opioid dependent patients undergoing orthopedic surgeries

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016070211662N10
Enrollment
144
Registered
2016-09-09
Start date
2016-07-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Acute pain. Acute Pain

Interventions

Intervention 1: In the group A, after induction of anesthesia,lidocaine will be started with a bolus 1.5 mg/kg followed by infusion 2 mg/kg per hour up tp the end of the surgery. Intervention 2: In
Treatment - Drugs
In the group A, after induction of anesthesia,lidocaine will be started with a bolus 1.5 mg/kg followed by infusion 2 mg/kg per hour up tp the end of the surgery.
In the group B, after induction of anesthesia, Ketamine will be administered as a 0.5mg/kg bolus, followed by an infusion of 0.2 mg/kg per hour up to end of surgery.
In the control group , after induction of anesthesia, normal saline will be started as a bolus ,followed by an infusion up to end of surgery.

Sponsors

Vice-Chancellery of Research and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: The eligible participants were all opioid dependent patients aging 20-50 years who were candidate for orthopedic bone surgery under general anesthesia. Exclusion criteria: patients having the history of cardiovascular disorders; seizure disorder; psychiatric disorder; renal or hepatic dysfunction;taking illicit medications; hypersensitivity to local anesthetic drugs; other anesthetic method and ASA class more than III .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Postoperative analgesia. Timepoint: Every 15 min after patients will become awake in post anesthesia care unit (PACU). During the first 24 h postoperative analgesia will be evaluated every 2 hr for 8 hr then every 4 hr till 24 hr. Method of measurement: By using Numerical Rating Pain Score (0= No pain,..10= the most severe pain that could imagine).

Secondary

MeasureTime frame
Sedation. Timepoint: every 15 minute in PACU (post anesthesia care unit ). Method of measurement: By using sedation scale: 0 = Restless , 1 = Calm, 2 = Sleepy, 3 = Drowsy with response to verbal stimuli , 4 = Drowsy without response to verbal stimuli, 5 = Without response to painfull stimuli.;Patients satisfaction. Timepoint: Every 4 hr during first 24 hr post operation. Method of measurement: Patients satisfaction score : 0 = Completely unsatisfied 1 = Unsatisfied 2 = Neutral 3 = Satisfied 4 = Completely satisfied.;Postoperative nausea and vomiting. Timepoint: Every 4 hr during first 24 hr post operation. Method of measurement: By using 3-point scale: 0 = no nausea, vomiting, 1 = nausea only, and 2 = retching or/and vomiting.;Repiratory depression. Timepoint: Every 4 hr during first 24 hr post operation. Method of measurement: Difined as repiratory rate < 8/min.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Ali Sahmeddini

Shiraz University Of Medical Sciences

sahmeddini@sums.ac.ir+98 71 3647 4270

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026