Clinical Trial for the assessment of treatment efficacy with a gas mixture of equal parts (50/50) of nitrous oxide (N2O) and oxygen (O2) in renal colic.

PHASE IV RANDOMIZED DOUBLE BLINDED AND MULTICENTER CLINICAL TRIAL FOR THE EVALUATION OF AN OXIGEN AND NITROUS OXIDE 50/50 MIXTURE USE IN RENAL COLIC TREATMENT BY AN EMERGENCY SERVICE. - CLINICAL TRIAL FOR THE EVALUATION OF A MIXTURE O2 + N2O IN RENAL COLIC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000200-15-ES

Enrollment

242

Registered

2012-04-17

Start date

2012-05-29

Completion date

Unknown

Last updated

2016-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RENAL COLIC

Interventions

Trade Name: Entonox Product Name: Oxido nitroso Product Code: N01AX63 Pharmaceutical Form: Inhalation gas INN or Proposed INN: 71597 CAS Number: 10024-97-2 Current Sponsor code: Entonox Other descript

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age ? 18 years. Low back pain irradiated or not. Colic in nature. Pain by pressure in the same side of pain. 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 242 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients <18 years. ? Patients who do not meet criteria for the diagnosis of renal colic. ? Patients with allergy or intolerance to either drug used in the study (dexketoprofen, metamizol, metoclorpropamida and / or pethidine). Pregnant patients, applying the usual clinical management of patients with suspected renal colic. Be considered as not pregnant the patient who has not presented late in their menstrual cycle and that denies the possibility of pregnancy and / or using effective contraception or menopausal patient. ? breast feeding patients. ? Patients with clinically significant psychiatric condition at the discretion of the physician. ? Patients with absolute or relative contraindication for the use of N2O/O2 50/50: or unable to work and / or altered level of consciousness. o pneumothorax. or with significant abdominal distension and / or suspected bowel obstruction. o severe bullous emphysema. or a history of recent diving (in the last 7 days). or have suffered a head injury. o those who have made recent intraocular injection of gas (in the last 7 days). o which they have made a surgical procedure in the middle ear. or oxygen saturation <94%. o known deficiency of vitamin B12 or folic

Design outcomes

Primary

Measure	Time frame
Main Objective: Check whether the use of a mixture of oxygen and nitrous oxide 50/50 reduces time to decrease the pain and its intensity compared to conventional analgesic treatment.;Secondary Objective: Check if the gas mixture decreases the number of drugs needed to relieve pain, opioid use, how long the patient stays in the emergency department, the need for admission and performance of ultrasound. Also as an additional objective analyze the economic impact and patient satisfaction using this gas compared to conventional treatment.;Primary end point(s): The main objective is to test whether the use of a mixture of oxygen and nitrous oxide 50/50 reduces the time to reduce pain and its intensity compared to conventional analgesic treatment, and patient satisfaction with treatment given prior at discharge.;Timepoint(s) of evaluation of this end point: Main outcomes: pain intensity measured by VAS as well as patient satisfaction with treatment given prior to discharge	—

Measure

Time frame

Main Objective: Check whether the use of a mixture of oxygen and nitrous oxide 50/50 reduces time to decrease the pain and its intensity compared to conventional analgesic treatment.;Secondary Objective: Check if the gas mixture decreases the number of drugs needed to relieve pain, opioid use, how long the patient stays in the emergency department, the need for admission and performance of ultrasound. Also as an additional objective analyze the economic impact and patient satisfaction using this gas compared to conventional treatment.;Primary end point(s): The main objective is to test whether the use of a mixture of oxygen and nitrous oxide 50/50 reduces the time to reduce pain and its intensity compared to conventional analgesic treatment, and patient satisfaction with treatment given prior at discharge.;Timepoint(s) of evaluation of this end point: Main outcomes: pain intensity measured by VAS as well as patient satisfaction with treatment given prior to discharge

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Secondary

Measure	Time frame
Secondary end point(s): Secondary objectives ascertain whether the mixture of gases decreases the number of drugs needed to relieve pain, opioid use, how long the patient stays in the emergency department, the need for admission and performance of ultrasound. Also as an additional objective and analyze the economic impact on patient satisfaction from the use of this gas compared to conventional treatment;Timepoint(s) of evaluation of this end point: Secondary outcomes: - Number of drugs to achieve symptomatic control. - Degree of sedation as measured by Modified Observer's Assessment of Alertness Sedation Scale (OAA / S) . - Number of patients requiring opioids. - Side Effects. - Time elapsed between admission and discharge from the emergency. - Degree of patient satisfaction. - Demographic variables: age, sex and race. - Physical variables: blood pressure, heart rate, temperature and oxygen saturation. - Investigations: X-ray of abdomen, white blood cell count, hemoglobin, creatinine, urinalysis and ultrasound (the latter only in cases deemed necessary by the clinician caring for the patient).	—

Measure

Time frame

Secondary end point(s): Secondary objectives ascertain whether the mixture of gases decreases the number of drugs needed to relieve pain, opioid use, how long the patient stays in the emergency department, the need for admission and performance of ultrasound. Also as an additional objective and analyze the economic impact on patient satisfaction from the use of this gas compared to conventional treatment;Timepoint(s) of evaluation of this end point: Secondary outcomes: - Number of drugs to achieve symptomatic control. - Degree of sedation as measured by Modified Observer's Assessment of Alertness Sedation Scale (OAA / S) . - Number of patients requiring opioids. - Side Effects. - Time elapsed between admission and discharge from the emergency. - Degree of patient satisfaction. - Demographic variables: age, sex and race. - Physical variables: blood pressure, heart rate, temperature and oxygen saturation. - Investigations: X-ray of abdomen, white blood cell count, hemoglobin, creatinine, urinalysis and ultrasound (the latter only in cases deemed necessary by the clinician caring for the patient).

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Countries

Spain

Contacts

Public ContactAna Maria Tello

Fundacion de Investigacion Biiomedica

anamaria.tello@salud.madrid.org+3491520 22 00 17524

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026