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Intraoperative Use of Dexketoprofen Trometamol, Pethidine Hcl, Tramadol Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by GOKHAN GOKMEN, Kavaklıdere Umut Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01558622
First Posted: March 20, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GOKHAN GOKMEN, Kavaklıdere Umut Hospital
  Purpose
The purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol, tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic Nissen fundoplication.

Condition Intervention Phase
Laparoscopic Nissen Fundoplication Drug: dexketoprofen trometamol Drug: tramadol hydrochloride Drug: pethidine hydrochloride Drug: dexketoprofen trometamol + tramadol hydrochloride Drug: dexketoprofen trometamol + pethidine hydrochloride Drug: vitamin c Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Intraoperative Use of Dexketoprofen Trometamol, Tramadol Hcl, Pethidine Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication

Resource links provided by NLM:


Further study details as provided by GOKHAN GOKMEN, Kavaklıdere Umut Hospital:

Primary Outcome Measures:
  • Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35 [ Time Frame: postoperative 2 hours ]

Estimated Enrollment: 72
Study Start Date: March 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: dexketoprofen trometamol
Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen.
Drug: dexketoprofen trometamol
50mg intravenous infusion
Placebo Comparator: tramadol hydrochloride
Tramadol Hydrochloride is a well-known centrally acting opioid pain killer.
Drug: tramadol hydrochloride
100mg intravenous infusion
Placebo Comparator: pethidine hydrochloride
Pethidine is a synthetic opioid analgesic which produces a pattern of effects similar to morphine the standard against which opioid analgesics are compared.
Drug: pethidine hydrochloride
50mg intravenous infusion
Placebo Comparator: dexketoprofen trometamol + tramadol hydrochloride Drug: dexketoprofen trometamol + tramadol hydrochloride
intravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride
Placebo Comparator: dexketoprofen trometamol + pethidine hydrochloride Drug: dexketoprofen trometamol + pethidine hydrochloride
intravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride
Placebo Comparator: vitamin c Drug: vitamin c
500mg intravenous infusion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-60 years old ASA I-II patients
  • Clinical diagnosis of gastroesophageal reflux patients

Exclusion Criteria:

  • Allergic reactions to NSAIDs or opioid analgesics
  • Body mass index exceeding 35
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558622


Locations
Turkey
Kavaklidere Umut Hospital
Ankara, Turkey, 06660
Sponsors and Collaborators
Kavaklıdere Umut Hospital
Investigators
Principal Investigator: GOKHAN GOKMEN, Specialist
  More Information

Responsible Party: GOKHAN GOKMEN, Anesthesiologist, MD, Kavaklıdere Umut Hospital
ClinicalTrials.gov Identifier: NCT01558622     History of Changes
Other Study ID Numbers: KVDU 0001 GG
First Submitted: March 16, 2012
First Posted: March 20, 2012
Last Update Posted: October 12, 2017
Last Verified: March 2012

Keywords provided by GOKHAN GOKMEN, Kavaklıdere Umut Hospital:
postoperative analgesia
dexketoprofen trometamol
tramadol hydrochloride
pethidine
laparoscopic Nissen fundoplication

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Vitamins
Ascorbic Acid
Tramadol
Meperidine
Dexketoprofen trometamol
Ketoprofen
Micronutrients
Growth Substances
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Adjuvants, Anesthesia
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents