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

Sponsor

Kavaklıdere Umut Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01558622

Collaborator

(none)

Enrollment

Location

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

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

Study Start Date :

Mar 1, 2012

Anticipated Primary Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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