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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03437707
Other study ID # sedatakbas2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 13, 2018
Est. completion date August 13, 2018

Study information

Verified date August 2018
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary aim of this prospective, randomized, double-blind, placebo-controlled clinical trial is to compare the analgesic effects of IV ibuprofen and paracetamol on postoperative pain, and secondary aim is the effects on morphine consumption and side effects of morphine in patients who underwent lumbar disc surgery with a single level laminectomy or discectomy.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Morphine Sulfate
Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Intravenous paracetamol
1 g paracetamol will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Intravenous ibuprofen
800 mg ibuprofen (diluted with 250 ml saline) will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.

Locations

Country Name City State
Turkey Sedat AKBAS Malatya Türkiye-Türkçe

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Tunali Y, Akçil EF, Dilmen OK, Tutuncu AC, Koksal GM, Akbas S, Vehid H, Yentur E. Efficacy of intravenous paracetamol and dexketoprofen on postoperative pain and morphine consumption after a lumbar disk surgery. J Neurosurg Anesthesiol. 2013 Apr;25(2):143 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain scores Visual Analog Scale (VAS, 0-10) From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
Secondary Sedation score Ramsey sedation score (1-6) From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
Secondary Morphine consumption Morphine From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
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