Development of a New Method for Analgesia

Ove Andersen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Analgesia

Treatments: Drug: lidocaine suspension; Drug: CRC-Pharma 001

Study type: Interventional

Funder types: Other

Identifiers

NCT00791024

CRC06

Details and patient eligibility

About

Aim: To examine a new method to perform local anesthesia in order to diminish the inconvenience by the procedure in patients before performing intubation or oesophagogastroduodenoscopy.

Full description

A phase one and two study. part one is performed as a single arm unblinded uncontrolled study in 16 obese patients undergoing awake intubation (investigational pill). The second part is a phase two study randomized single blinded study in 100 patient attending a day case endoscopy unit for oesophagogastroduodenoscopy (investigational pill versus lidocaine suspension).

Enrollment: 126 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients admitted for adipositas surgery
• Patients who attend for oesophagogastroduodenoscopy.

Exclusion criteria

• Severe psychiatric diseases
• Alcohol abuse

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 1 patient group

single arm

Experimental group

Treatment:

Drug: lidocaine suspension

Drug: CRC-Pharma 001