| Protocol ID | NCT01326325 |
| Registration Date | 2011-03-30 |
| Status | completed |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Country | France |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2011-07-01 |
| Last Patient Out | 2013-06-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT01326325
Study of the Efficiency of the Ketamine With Low Analgesic Doses, in Association With High Opioids, in the Treatment of the Rebels Pains, in Palliative Phase of the Cancerous Disease
| Field |
GLM
glm-5.1 7980ms / 9129 tok |
OPENAI
gpt-4o 5816ms / 8933 tok |
CLAUDE
claude-sonnet-4-20250514 4682ms / 10379 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | inpatient | inpatient | inpatient | OK |
| setting_place | hospital | hospital | hospital | OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic | yes | yes | yes | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All primary and secondary outcomes (pain score, patient/clinician global impression of change, sleep interference score, patient satisfaction, opioid consumption, and adverse effects) fall under the symptom category for a palliative population.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — All outcomes focus on pain relief, symptoms, patient satisfaction, and adverse events, which fit within symptom/QoL categories.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All outcomes focus on pain relief, symptom management (adverse effects), and quality of life measures (sleep interference, satisfaction), which are core palliative care symptom/QoL categories.
|
OK |
| pharmacologic_sub | controlled substances | controlled substances | controlled substances | OK |