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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001690-99 | EudraCT Number |
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| Name | Class |
|---|---|
| Chiltern International Ltd. | INDUSTRY |
| HFL Ltd. | UNKNOWN |
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To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24 hour post-operative period. Pain relief and nausea will be determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M6G | Experimental | An initial slow bolus injection up to 60 min prior to end of surgery. If required, two additional slow bolus injections to achieve baseline pain relief. Continuing on PCA for a minimum of 24 hours. |
|
| Morphine | Active Comparator | An initial slow bolus injection up to 60 min prior to end of surgery. If required, two additional slow bolus injections to achieve baseline pain relief. Continuing on PCA for a minimum of 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine 6-glucuronide | Drug |
| ||
| Morphine |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of nausea | To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24-hour post-operative period. Pain relief and nausea were determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores. | The 6-18 hour period after titration to pain relief |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic effect | To compare the analgesic effect of the study treatments using an Investigator- and patient-administered VRS-11 scale of pain intensity over the following time periods following achievement of baseline pain relief.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Binning, M.D. | Intensive Care Unit, Level 5, Western Infirmary, Glasgow, G11 6NT | Principal Investigator |
| James Lees, B.Sc. | Paion UK Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teaching Hospital Bulovka, Department of Urology | Prague | 180 00 | Czechia | |||
| Anaesthetisia - Resuscitation Department, Tenon Hospital |
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|
| 0-48 hours after titration to pain relief |
| The incidence and severity of nausea | To compare the incidence and severity of nausea in the study treatment groups over the following time periods following achievement of baseline pain relief: 0-12 hours, 0-24 hours, 0-48 hours, 12-24 hours, 24-48 hours. | 0-48 hours |
| The incidence and severity of vomiting | To compare the incidence and severity of vomiting in the study treatment groups over the following time periods following achievement of baseline pain relief: 0-12 hours, 0-24 hours, 0-48 hours, 12-24 hours, 24-48 hours | 0-48 hours |
| The amounts of study drug required to achieve a baseline pain severity score of ≤ 3 | To compare the amounts of study drug required to achieve a baseline pain severity score of ≤ 3 | 60-30mins before close of surgery to time 0. |
| Paris |
| Cedex 20 |
| 75970 |
| France |
| Universitätsklinikum Bonn, Klinik und Poliklinik f. Anaesthesiologie | Bonn | 53105 | Germany |
| Department of Anaesthesiology, Leiden University Medical Centre | Leiden | 2300 RC | Netherlands |
| Ii Klinika Anestezjologii i It | Lublin | 20-081 | Poland |
| Intensive Care Unit, Level 5, Western Infirmary, | Glasgow | Renfrewshire | G11 6NT | United Kingdom |
| St John's Hospital | Livingston | West Lothian | EH54 6PP | United Kingdom |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| C035349 | morphine-6-glucuronide |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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