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

Kavaklıdere Umut Hospital

Status and phase: Unknown; Phase 4

Conditions: Laparoscopic Nissen Fundoplication

Treatments: Drug: pethidine hydrochloride; Drug: dexketoprofen trometamol; Drug: dexketoprofen trometamol + pethidine hydrochloride; Drug: dexketoprofen trometamol + tramadol hydrochloride; Drug: tramadol hydrochloride; Drug: vitamin c

Study type: Interventional

Funder types: Other

Identifiers

NCT01558622

KVDU 0001 GG

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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72 participants in 6 patient groups, including a placebo group

dexketoprofen trometamol

Placebo Comparator group

Description:

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

Treatment:

Drug: dexketoprofen trometamol

tramadol hydrochloride

Placebo Comparator group

Description:

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

Treatment:

Drug: tramadol hydrochloride

pethidine hydrochloride

Placebo Comparator group

Description:

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

Treatment:

Drug: pethidine hydrochloride

dexketoprofen trometamol + tramadol hydrochloride

Placebo Comparator group

Treatment:

Drug: dexketoprofen trometamol + tramadol hydrochloride

dexketoprofen trometamol + pethidine hydrochloride

Placebo Comparator group

Treatment:

Drug: dexketoprofen trometamol + pethidine hydrochloride

vitamin c

Placebo Comparator group

Treatment:

Drug: vitamin c