Symptoms and General Pathology

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Pain

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Arrhythmia Agents

Channel Blockers

Pharmaceutical Solutions

Analgesics

Anticonvulsants

Psychotropic Drugs

Antipyretics

Anesthetics

Lidocaine

Bupivacaine

Morphine

Anesthetics, Local

Gabapentin

Acetaminophen

Sodium Channel Blockers

Diuretics, Potassium Sparing

Analgesics, Opioid

Narcotics

Analgesics, Non-Narcotic

Anti-Anxiety Agents

Excitatory Amino Acid Antagonists

Neurotransmitter Agents

The patients can take up to eight 25 mg bupivacaine lozenges (max. every second hour in the awake hours) a day for seven days. The patients can use concomitant systemic pain treatment (e.g. morphine).

The patients will be treated with the currently used standard pain treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin). The anesthetics are being administered at the physician's discretion.

Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin

Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)

Claus A Kristensen, MD, PhD

Jens Bentzen, MD

Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and painful adverse effect caused by the radio therapy and/or chemo therapy patients with head and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the current treatment with opioids is not sufficient and can cause adverse effects.

Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce the oral pain caused by mucositis compared with the current standard treatment.

Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

Clinical Trial With Lozenges as Local Anesthetic Treatment for Head/Neck Cancer Patients With Oral Mucositis

The primary outcome measure is the mean VAS score for the patients in the bupivacaine lozenge group compared with the mean VAS score for the patients in the standard treatment group.

The lozenge group measures VAS before and 60 min. after administration of a lozenge for seven days. The standard treatment group measures VAS every second hour for seven days.

Mean value of the pain score (VAS) measured 120 minuts after the administration of a lozenge for the patients receiving the lozenges compared with the mean value of the pain score (VAS) measured every second hour for the patients receiving the standard treatment.

The difference in pain score (VAS) between the first score in the morning before the first lozenge of the day and the score 60 minuts after the administration of the lozenge. Pain is scored both in the oral cavity and the pharynx.

The first ten patients receiving the bupivacaine lozenge will on day seven (the last day of their treatment period) get blood samples drawn before a lozenge is administrated and at time 30 min, 60 min. and 90 min. after the administration.

Moberg Pharma, Sweden

Hvidovre University Hospital

MD, PhD

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Hemorrhage

Postoperative Hemorrhage

Seroma

Breast Diseases

Skin Diseases

Inflammation

Postoperative Complications

Coagulants

Tranexamic Acid

Antifibrinolytic Agents

Hemostatics

tranexamic acid to be smeared on surgical wounds before closure

saline to be smeared on surgical wounds before closure

moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml

moisten the surgical wound surface with 20 ml placebo (0.9% saline)

saline

Petter Aadahl, MD PhD

Sverrir Olafsson

After surgical procedures, interventions to reduce postoperative bleeding are of great importance. In this study, the effect will be investigated of smearing tranexamic acid, which is designed for injection, directly onto the raw wound surface (topical application) created during surgery. Topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. The researchers have recently shown that topically applicated tranexamic acid reduces bleeding in women who had two-sided breast reduction surgery. Now it will be studied whether topically applicated tranexamic acid reduces bleeding after breast surgery for breast cancer.

After surgery for breast cancer patients may also experience problems with long lasting seroma. Therefore it will at the same time be investigated whether topical tranexamic acid reduces the development of seroma in these patients.

The Effect of Topical Tranexamic Acid on Bleeding and Seroma Formation in After Undergoing Mastectomy

The Effect of Topical Administration of Tranexamic Acid on Postoperative Bleeding and Seroma Formation in Patients Undergoing Mastectomy: A Prospective Placebo-controlled Double Blinded Randomized Study

Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml

Alesund Hospital

St. Olavs Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Local Anesthetic Treatment of Oral Pain in Patients With Mucositis	NCT02252926	Mucositis	Bupivacaine Standard treatm...	18 Years - 80 Years	Hvidovre University Hospital
The Effect of Topical Tranexamic Acid on Bleeding and Seroma Formation in After Undergoing Mastectomy	NCT02627560	Postoperative H... Breast Neoplasm... Seroma	Tranexamic Acid saline	18 Years -	St. Olavs Hospital

Spots Global Cancer Trial Database for administration, topical