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Phase 3 N=230 Randomized Double-blind Treatment

Administration of Ketamine to Prevent the Post-operative Pain

Postoperative Pain · Breast Cancer

Enrolled (actual)
230
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Morphine Consumption (First 48 Post-operative Hours) — 79; 77 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Ketamine (Drug); Saline solution (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Institut Bergonié
Primary completion
Jul 2005

Outcome Measures

OutcomeResultp-value
PRIMARY
Morphine Consumption (First 48 Post-operative Hours)
79; 77
SECONDARY
Post-operative Pain
106; 102; 3; 2

Summary

The surgery of breast cancer is responsible for post-operative pain, needing in about 30% some morphine consumption; like that, the association of ketamine with general anaesthesia may decrease morphine's use and so its adverse effects. The purpose is to evaluate the analgesic effect of a receptor NMDA's antagonist ( ketamine)

Eligibility Criteria

Inclusion criteria

  • Patients 18 years older
  • ASA class 1 or 2
  • with surgery of breast cancer (mastectomy or tumorectomy)

Exclusion criteria

.Kétamine hypersensitivity

  • Major psychiatric disorders
  • Major cardio-vascular disorders
  • Major neurologic disorders
  • Major ocular disorders
  • Morphine in pre-operative period
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00210210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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