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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01558622
Date of registration: 16/03/2012
Prospective Registration: No
Primary sponsor: Kavaklidere Umut Hospital
Public title: Intraoperative Use of Dexketoprofen Trometamol, Pethidine Hcl, Tramadol Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication
Scientific title: Intraoperative Use of Dexketoprofen Trometamol, Tramadol Hcl, Pethidine Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication
Date of first enrolment: March 2012
Target sample size: 72
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT01558622
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Turkey
Contacts
Name:     GOKHAN GOKMEN, Specialist
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Laparoscopic Nissen Fundoplication
Intervention(s)
Drug: dexketoprofen trometamol
Drug: dexketoprofen trometamol + pethidine hydrochloride
Drug: dexketoprofen trometamol + tramadol hydrochloride
Drug: tramadol hydrochloride
Drug: pethidine hydrochloride
Drug: vitamin c
Primary Outcome(s)
Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35 [Time Frame: postoperative 2 hours]
Secondary Outcome(s)
Secondary ID(s)
KVDU 0001 GG
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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