Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexketoprofen trometamol | Placebo Comparator | Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen. |
|
| tramadol hydrochloride | Placebo Comparator | Tramadol Hydrochloride is a well-known centrally acting opioid pain killer. |
|
| pethidine hydrochloride | 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. |
|
| dexketoprofen trometamol + tramadol hydrochloride | Placebo Comparator |
| |
| dexketoprofen trometamol + pethidine hydrochloride | Placebo Comparator |
| |
| vitamin c | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexketoprofen trometamol | Drug | 50mg intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35 | postoperative 2 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GOKHAN GOKMEN, Specialist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kavaklidere Umut Hospital | Ankara | 06660 | Turkey (Türkiye) |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 27, 2012 | |
| Unrelease | Yes | |
| Release | Aug 6, 2012 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| tramadol hydrochloride |
| Drug |
100mg intravenous infusion |
|
| pethidine hydrochloride | Drug | 50mg intravenous infusion |
|
| dexketoprofen trometamol + tramadol hydrochloride | Drug | intravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride |
|
| dexketoprofen trometamol + pethidine hydrochloride | Drug | intravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride |
|
| vitamin c | Drug | 500mg intravenous infusion |
|
| Unrelease | Yes |
| Release | Aug 11, 2012 |
| Reset | Sep 10, 2012 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 27, 2012 | Yes | |||
| Aug 6, 2012 | Yes | |||
| Aug 11, 2012 | Sep 10, 2012 |
| ID | Term |
|---|---|
| C118296 | dexketoprofen trometamol |
| D014147 | Tramadol |
| D008614 | Meperidine |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
Not provided
Not provided