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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GOKHAN GOKMEN, Kavaklıdere Umut Hospital
ClinicalTrials.gov Identifier:
NCT01558622
First received: March 16, 2012
Last updated: March 22, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
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:

MedlinePlus related topics: Vitamin C
U.S. FDA Resources

Further study details as provided by Kavaklıdere Umut Hospital:

Primary Outcome Measures:
  • Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35 [ Time Frame: postoperative 2 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558622

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

No publications provided

Responsible Party: GOKHAN GOKMEN, Anesthesiologist, MD, Kavaklıdere Umut Hospital
ClinicalTrials.gov Identifier: NCT01558622     History of Changes
Other Study ID Numbers: KVDU 0001 GG
Study First Received: March 16, 2012
Last Updated: March 22, 2012
Health Authority: Turkey: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 21, 2013