Trial Outcomes & Findings for Administration of Ketamine to Prevent the Post-operative Pain (NCT NCT00210210)

NCT ID: NCT00210210

Last Updated: 2025-09-19

Results Overview

Number of participants with at least one consumption of morphine within 48 hours following surgery.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 230 participants
• Primary outcome timeframe: within 48 hours following surgery
• Results posted on: 2025-09-19

Participant Flow

Participant milestones

Measure	Ketamine Arm Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol". Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol". Ketamine	Reference Arm Induction and anesthetic maintenance without ketamine (reference arm / saline solution) Saline solution
Overall Study STARTED	115	115
Overall Study COMPLETED	109	104
Overall Study NOT COMPLETED	6	11

Reasons for withdrawal

Measure	Ketamine Arm Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol". Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol". Ketamine	Reference Arm Induction and anesthetic maintenance without ketamine (reference arm / saline solution) Saline solution
Overall Study Withdrawal by Subject	3	2
Overall Study absence of lymph node dissection after intraoperative frozen section of the specimen	3	9

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ketamine Arm n=109 Participants Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol". Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol". Ketamine	Reference Arm n=104 Participants Induction and anesthetic maintenance without ketamine (reference arm / saline solution) Saline solution	Total n=213 Participants Total of all reporting groups
Age, Continuous	57.4 years STANDARD_DEVIATION 12.3 • n=109 Participants	58.8 years STANDARD_DEVIATION 11.4 • n=104 Participants	58 years STANDARD_DEVIATION 12 • n=213 Participants
Sex: Female, Male Female	109 Participants n=109 Participants	104 Participants n=104 Participants	213 Participants n=213 Participants
Sex: Female, Male Male	0 Participants n=109 Participants	0 Participants n=104 Participants	0 Participants n=213 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	109 participants n=109 Participants	104 participants n=104 Participants	213 participants n=213 Participants

PRIMARY outcome

Timeframe: within 48 hours following surgery

Number of participants with at least one consumption of morphine within 48 hours following surgery.

Outcome measures

Measure	Ketamine Arm n=109 Participants Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol". Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol". Ketamine	Reference Arm n=104 Participants Induction and anesthetic maintenance without ketamine (reference arm / saline solution) Saline solution
Morphine Consumption (First 48 Post-operative Hours)	79 Participants	77 Participants

SECONDARY outcome

Timeframe: 48 hours after surgery

Count of participants with post-operative pain. Pain was measured using a Visual Analog Rating Scale (VAS), ranging from 0 (no pain) to 10 (pain).

A VAS score >= 4 wwas considered as "Pain". A VAS sore <4 was considered as "No pain".

Outcome measures

Measure	Ketamine Arm n=109 Participants Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol". Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol". Ketamine	Reference Arm n=104 Participants Induction and anesthetic maintenance without ketamine (reference arm / saline solution) Saline solution
Post-operative Pain No pain (VAS < 4)	106 Participants	102 Participants
Post-operative Pain Pain (VAS >= 4)	3 Participants	2 Participants

Adverse Events

Ketamine Arm

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Reference Arm

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ketamine Arm n=109 participants at risk Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol". Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol". Ketamine	Reference Arm n=104 participants at risk Induction and anesthetic maintenance without ketamine (reference arm / saline solution) Saline solution
Gastrointestinal disorders Nausea	7.3% 8/109 • Number of events 8 • 6 months after surgery	7.7% 8/104 • Number of events 8 • 6 months after surgery
Gastrointestinal disorders Vomiting NOS	11.0% 12/109 • Number of events 12 • 6 months after surgery	11.5% 12/104 • Number of events 12 • 6 months after surgery

Additional Information

Simone Mathoulin-Pélissier, Director of Clinical Trials' Unit

Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

Phone: +33 5 56 33 33 33

Email: s.mathoulin@bordeaux.unicancer.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place