Pain associated to hysteroscopy procedures
Conditions
Interventions
Trade Name: Kalinox
Product Name: Nitrous Oxide 50% - Oxygen 50%
Pharmaceutical Form: Medicinal gas, compressed
INN or Proposed INN: Kalinox
CAS Number: 10024-97-2
Other descriptive name: NITROUS OXID
Sponsors
FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO PRINCIPE DE ASTURIAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women over 18 years. - Patients candidates for conducting hysteroscopy, referred from the gynecology clinics. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 297 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Patients with allergies or contraindications to the study drugs. - Deficiency of vitamin B12 or folic acid documented and untreated. - Neurological abnormalities unexplained and recent onset. - Patients who are pregnant or who might become pregnant. - Women breastfeeding. - Patients treated with other depressants of the central nervous system such as opiates, benzodiazepines and other psychotropic drugs. - Patients not fluent in Spanish language. - Inability to grant informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether equimolar mixture of oxygen and nitrous oxide (Kalinox ®) has a greater effect on pain control during hysteroscopy compared with paracervical local anesthesia with lidocaine 1% and with no analgesic treatment, with a difference of 30 points or more, as measured by the visual analog scale (VAS), in the mean perceived pain during hysteroscopy.;Secondary Objective: - To evaluate the safety and tolerability of the equimolar mixture of oxygen and nitrous oxide 50% during diagnostic hysteroscopy compared with paracervical local anesthesia with lidocaine 1 % and the control group without analgesic treatment. - Assess patient satisfaction with the procedure. - Perception of pain by the investigator in the different methods of analgesia - Match the analgesic effect of each treatment during hysteroscopy with procedures determined by the different variables such as : hysteroscopy indication , duration of procedure , techniques performed ( diagnostic hysteroscopy / polypectomy / insertion of Essure device), hysteroscopic findings and complications produced . - Compare the vital signs of each patient before, during and after the procedure with different types of analgesia. - Assess the impact of medical and socio-cultural variables that influence the analgesic effect.;Primary end point(s): Pain felt during the histeroscopy procedure measured by the visual analog scale (VAS) within a range of 0 to 100 where 0 is no pain at all and 100 is the most intense pain felt ever.;Timepoint(s) of evaluation of this end point: The different histeroscopy procedures last 10 minutes in average | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability Satisfaction level with the technique Pain felt by the patient perceived by the investigator To evaluate the analgesic effects related to the different indications of the histeroscopy. To compare de vital signs before, during and after the procedure. To assess the sociocultural and medical conditions with the analgesic effect.;Timepoint(s) of evaluation of this end point: During the histeroscopy procedure and the day after via telephone contact. | — |
Countries
Spain
Contacts
Public ContactFarmacologia Clinica
Fundacion para la Investigación Biomedica del Hospital Universitario Principe de Asturias
Outcome results
None listed