This trial is active, not recruiting.

Condition laparoscopic nissen fundoplication
Treatments dexketoprofen trometamol, tramadol hydrochloride, pethidine hydrochloride, dexketoprofen trometamol + tramadol hydrochloride, dexketoprofen trometamol + pethidine hydrochloride, vitamin c
Phase phase 4
Sponsor Kavaklıdere Umut Hospital
Start date March 2012
End date May 2012
Trial size 72 participants
Trial identifier NCT01558622, KVDU 0001 GG


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
(Placebo Comparator)
Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen.
dexketoprofen trometamol
50mg intravenous infusion
(Placebo Comparator)
Tramadol Hydrochloride is a well-known centrally acting opioid pain killer.
tramadol hydrochloride
100mg intravenous infusion
(Placebo Comparator)
Pethidine is a synthetic opioid analgesic which produces a pattern of effects similar to morphine the standard against which opioid analgesics are compared.
pethidine hydrochloride
50mg intravenous infusion
(Placebo Comparator)
dexketoprofen trometamol + tramadol hydrochloride
intravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride
(Placebo Comparator)
dexketoprofen trometamol + pethidine hydrochloride
intravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride
(Placebo Comparator)
vitamin c
500mg intravenous infusion

Primary Outcomes

Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35
time frame: postoperative 2 hours

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Intraoperative Use of Dexketoprofen Trometamol, Tramadol Hcl, Pethidine Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication
Principal investigator GOKHAN GOKMEN, Specialist
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Kavaklıdere Umut Hospital.