Effect of a Topical Ketamine on Acute and Chronic Pain, Dose Finding

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: group (B); Drug: group (A); Drug: group (c)

Study type: Interventional

Funder types: Other

Identifiers

NCT03165149

17100205

Details and patient eligibility

About

The aim of this study is to investigate the effect of addition of different doses of Ketamine locally in acute and chronic post-mastectomy pain after breast cancer surgery and on the probability of developing chronic post-mastectomy pain.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American society of heart association class I-II female patients

• aged 18-60 years
• scheduled for modified radical mastectomy with axillary dissection for breast carcinoma

Exclusion criteria

• known allergy to the study drugs
• significant cardiac-
• respiratory-
• renal or hepatic disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

90 participants in 3 patient groups

Group (A)

Active Comparator group

Description:

patients will receive 1mg / kg of Ketamine diluted by 20 ml saline (0.9 % )

Treatment:

Drug: group (A)

Group (B)

Active Comparator group

Description:

patients will receive 2 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) a

Treatment:

Drug: group (B)

Group (C)

Active Comparator group

Description:

patients will receive 3 mg / kg of Ketamine diluted by 20 ml saline (0.9 %)

Treatment:

Drug: group (c)