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

Primary Purpose

Laparoscopic Nissen Fundoplication

Status

Unknown status

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

dexketoprofen trometamol

tramadol hydrochloride

pethidine hydrochloride

dexketoprofen trometamol + tramadol hydrochloride

dexketoprofen trometamol + pethidine hydrochloride

vitamin c

About this trial

This is an interventional treatment trial for Laparoscopic Nissen Fundoplication focused on measuring postoperative analgesia, dexketoprofen trometamol, tramadol hydrochloride, pethidine, laparoscopic Nissen fundoplication

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kavaklidere Umut Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Arm Label

dexketoprofen trometamol

tramadol hydrochloride

pethidine hydrochloride

dexketoprofen trometamol + tramadol hydrochloride

dexketoprofen trometamol + pethidine hydrochloride

vitamin c

Arm Description

Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen.

Tramadol Hydrochloride is a well-known centrally acting opioid pain killer.

Pethidine is a synthetic opioid analgesic which produces a pattern of effects similar to morphine the standard against which opioid analgesics are compared.

Outcomes

Primary Outcome Measures

Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35

Secondary Outcome Measures

Full Information

NCT ID

NCT01558622

First Posted

March 16, 2012

Last Updated

March 22, 2012

Sponsor

Kavaklıdere Umut Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01558622

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

March 2012 (undefined)

Primary Completion Date

May 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kavaklıdere Umut Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Laparoscopic Nissen Fundoplication

Keywords

postoperative analgesia, dexketoprofen trometamol, tramadol hydrochloride, pethidine, laparoscopic Nissen fundoplication

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

dexketoprofen trometamol

Arm Type

Placebo Comparator

Arm Description

Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen.

Arm Title

tramadol hydrochloride

Arm Type

Placebo Comparator

Arm Description

Tramadol Hydrochloride is a well-known centrally acting opioid pain killer.

Arm Title

pethidine hydrochloride

Arm Type

Placebo Comparator

Arm Description

Pethidine is a synthetic opioid analgesic which produces a pattern of effects similar to morphine the standard against which opioid analgesics are compared.

Arm Title

dexketoprofen trometamol + tramadol hydrochloride

Arm Type

Placebo Comparator

Arm Title

dexketoprofen trometamol + pethidine hydrochloride

Arm Type

Placebo Comparator

Arm Title

vitamin c

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

dexketoprofen trometamol

Intervention Description

50mg intravenous infusion

Intervention Type

Drug

Intervention Name(s)

tramadol hydrochloride

Intervention Description

100mg intravenous infusion

Intervention Type

Drug

Intervention Name(s)

pethidine hydrochloride

Intervention Description

50mg intravenous infusion

Intervention Type

Drug

Intervention Name(s)

dexketoprofen trometamol + tramadol hydrochloride

Intervention Description

intravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride

Intervention Type

Drug

Intervention Name(s)

dexketoprofen trometamol + pethidine hydrochloride

Intervention Description

intravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride

Intervention Type

Drug

Intervention Name(s)

vitamin c

Intervention Description

500mg intravenous infusion

Primary Outcome Measure Information:

Title

Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35

Time Frame

postoperative 2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GOKHAN GOKMEN, Specialist

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kavaklidere Umut Hospital

City

Ankara

ZIP/Postal Code

06660

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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