Clinical trial with lozenges as local anesthesia for bone marrow transplant patients with oral pai

Phase 1

Conditions: Oral pain due to oral mucositis in patients undergoing a bone marrow transplant
MedDRA version: 14.1Level: LLTClassification code 10028130Term: Mucositis oralSystem Organ Class: 100000004856
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-000343-11-DK

Lead Sponsor: Clinical Research Centre, Hvidovre University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

- Scheduled for a bone marrow transplant
- Age between 18 and 80 years old
- Ability to speak, read and understand danish
- Ability to give written and oral consent
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Known allergy towards bupivacaine or other local analgesia of the amide type
- Pregnancy
- Breastfeeding women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: After administration of bupivacain lozenges the patients pain due to oral mucositis can be reduced, showed on a Visuel Analog Scale (VAS) 0-10, where as 0 = No pain and 10 = worst pain ever ;Secondary Objective: - Reduce the use of opioids administered by a Patient Controlles Analgesia (PCA) pump<br>- Improve the patients nutrition messuerede by weight and food intake<br>- Improve the patients quality og life messuerede by a questionnaire;Primary end point(s): VAS evaluation of oral pain when administration of the lozenge;Timepoint(s) of evaluation of this end point: Daily

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Timepoint for administration of the lozenge<br>- Number of lozenges administrated per day<br>- Opioid use administrated from a Patient controlled anesthesia (PCA) pump<br>- Number of failed attempt to get opioids from the PCA pump<br>- Weightloss<br>- Food intake ;Timepoint(s) of evaluation of this end point: Daily