NCT04831736

Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy

Completed Phase 4 Results posted Last updated 16 May 2023

What this trial tests

Phase 4 trial testing Ketamine in Postoperative Pain in 31 participants. Completed in 29 March 2022.

Timeline

26 April 2021

Primary endpoint
29 March 2022

29 March 2022

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	31
Start date	26 April 2021
Primary completion	29 March 2022
Estimated completion	29 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Ketamine (ketamine) — full drug profile →
• Placebo

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 18 to 80, female only, with Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score Primary · 24 Hours Post-Op (Day 2)

BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.

Group	Value	95% CI
Treatment	16.7	± 6.97
Control	18.1	± 8.44

Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score Primary · 48 Hours Post-Op (Day 3)

BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.

Group	Value	95% CI
Treatment	16	± 5.32
Control	15.7	± 9.36

Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score Secondary · Baseline (Day 0)

BPI Pain Severity Subscale is a 4-item questionnaire asking participants to rate pain. Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.

Group	Value	95% CI
Treatment	3.5	± 6.45
Control	2.2	± 5.37

Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score Secondary · Day 7 Post-Op (Day 8)

BPI Pain Severity Subscale is a 4-item questionnaire asking participants to rate pain. Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.

Group	Value	95% CI
Treatment	11.5	± 6.17
Control	15	± 8.68

Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score Secondary · Baseline (Day 0)

BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference.

Group	Value	95% CI
Treatment	35	± 18.29
Control	35	± 30.35

Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score Secondary · Day 1 Post-Op (Day 2)

BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference.

Group	Value	95% CI
Treatment	24.7	± 17.1
Control	28.1	± 14.9

Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score Secondary · Day 2 Post-Op (Day 3)

BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference.

Group	Value	95% CI
Treatment	33.5	± 12.5
Control	32.1	± 15.5

Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score Secondary · Day 7 Post-Op (Day 8)

BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference.

Group	Value	95% CI
Treatment	33.9	± 18.3
Control	32.9	± 15.1

Total Dosage of Opioid Use Secondary · Day of Surgery (Day 1)

Use and dosage will be assessed through medical records and subject reports.

Group	Value	95% CI
Treatment	6	± 7.06
Control	5	± 6.61

Total Dosage of Opioid Use Secondary · Day 1 Post-Op (Day 2)

Use and dosage will be assessed through medical records and subject reports.

Group	Value	95% CI
Treatment	21.5	± 17.9
Control	37.2	± 61.4

Total Dosage of Opioid Use Secondary · Day 2 Post-Op (Day 3)

Use and dosage will be assess through medical records and subject reports.

Group	Value	95% CI
Treatment	21.2	± 31.1
Control	18.5	± 21.2

Total Dosage of Opioid Use Secondary · Day 7 Post-Op (Day 8)

Use and dosage will be assess through medical records and subject reports.

Group	Value	95% CI
Treatment	0.833	± 2.25
Control	7	± 2.25

Sponsor's own description

This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6mg/kg) of ketamine versus placebo (saline) on postoperative pain on adult women undergoing mastectomy.

The objective of the study is to examine the effect of a subanesthetic dose (0.6mg/kg) of ketamine vs. saline control on postoperative pain in subjects who have undergone mastectomy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Single-Dose of Postoperative Ketamine for Postoperative Pain After Mastectomy: A Pilot Randomized Controlled Trial.
   Doan LV, Li A, Brake L, Ok D, et al · · 2023 · cited 6× · PMID 36942305 · DOI 10.2147/jpr.s389564