Trial Outcomes & Findings for Pain Medicine for Wound Care Procedures (NCT NCT00701909)

NCT ID: NCT00701909

Last Updated: 2024-03-26

Results Overview

The degree of pain described by participants on a numeric rating scale of 0 to 10, where 0 = no pain and 10 = worst pain imaginable

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 12 participants
• Primary outcome timeframe: Immediately after the wound care procedure
• Results posted on: 2024-03-26

Participant Flow

Participant milestones

Measure	Morphine Plus Ketamine, Then Morphine Plus Saline During the first wound care procedure, patients received morphine 0.05 mg/kg (a maximum dose of 4 mg) plus ketamine 0.25 mg/kg. Then, during the second wound care procedure, they were cross-over to receive morphine 0.1 mg/kg plus Saline.	Morphine Plus Saline, Then Morphine Plus Ketamine During the first wound care procedure, patients received morphine 0.1 mg/kg (a maximum dose of 8 mg) plus saline. Then, they were cross-over to receive morphine 0.05 mg/kg (a maximum dose of 4 mg) plus ketamine 0.25 mg/kg.
Overall Study STARTED	7	5
Overall Study COMPLETED	7	4
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Morphine Plus Ketamine, Then Morphine Plus Saline During the first wound care procedure, patients received morphine 0.05 mg/kg (a maximum dose of 4 mg) plus ketamine 0.25 mg/kg. Then, during the second wound care procedure, they were cross-over to receive morphine 0.1 mg/kg plus Saline.	Morphine Plus Saline, Then Morphine Plus Ketamine During the first wound care procedure, patients received morphine 0.1 mg/kg (a maximum dose of 8 mg) plus saline. Then, they were cross-over to receive morphine 0.05 mg/kg (a maximum dose of 4 mg) plus ketamine 0.25 mg/kg.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Pain Medicine for Wound Care Procedures

Baseline characteristics by cohort

Measure	Morphine Plus Ketamine First n=7 Participants During the first wound care procedure, patients received morphine 0.05 mg/kg (maximum dose of 4 mg) plus ketamine 0.25 mg/kg. Then, during the second wound care procedure, they received morphine 0.1 mg/kg (maximum dose of 8 mg) plus saline.	Morphine Plus Saline First n=4 Participants During the first wound care procedure, patients received morphine 0.1 mg/kg (maximum dose of 8 mg) plus saline. Then, during the second wound care procedure, they received morphine 0.05 mg/kg (maximum dose of 4 mg) plus ketamine 0.25 mg/kg.	Total n=11 Participants Total of all reporting groups
Age, Continuous	32.1 years STANDARD_DEVIATION 9.6 • n=5 Participants	32.5 years STANDARD_DEVIATION 4.4 • n=7 Participants	32.3 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Puerto Rico	7 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately after the wound care procedure

The degree of pain described by participants on a numeric rating scale of 0 to 10, where 0 = no pain and 10 = worst pain imaginable

Outcome measures

Measure	Morphine Plus Ketamine n=11 Participants Participants who received morphine 0.05 mg/kg (a maximum dose of 4 mg) plus ketamine 0.25 mg/kg IV in either the first or second wound care procedure.	Morphine Plus Saline n=11 Participants Participants who received morphine 0.1 mg/kg (a maximum dose of 8 mg) plus saline IV in either the first or second wound care procedure.
Pain Intensity	3.1 score on a scale Standard Error .99	6.8 score on a scale Standard Error .92

SECONDARY outcome

Timeframe: Immediately after the procedure

Short-form McGill Pain Questionnaire. The questionnaire has 15 adjectives to describe the pain. Each is rated on a 4-point scale (i.e., none, mild, moderate, or severe. Total wound pain quality score can range from 0 to 45.

Outcome measures

Measure	Morphine Plus Ketamine n=11 Participants Participants who received morphine 0.05 mg/kg (a maximum dose of 4 mg) plus ketamine 0.25 mg/kg IV in either the first or second wound care procedure.	Morphine Plus Saline n=11 Participants Participants who received morphine 0.1 mg/kg (a maximum dose of 8 mg) plus saline IV in either the first or second wound care procedure.
Wound Pain Quality	13.6 units on a scale Standard Error 3.6	17.6 units on a scale Standard Error 3.7

Adverse Events

Morphine Plus Ketamine

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Morphine Plus Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Morphine Plus Ketamine n=11 participants at risk Patients received morphine 0.05 mg/kg (maximum dose of 4 mg) plus ketamine 0.25 mg/kg (MK) during the first or second wound care procedure according to randomization	Morphine Plus Saline n=11 participants at risk Patients received morphine 0.1 mg/kg (maximum dose of 8 mg) plus saline (MS) during the first or second wound care procedure according to randomization
Nervous system disorders strange sensations	90.9% 10/11 • Number of events 10	0.00% 0/11

Additional Information

Dr. Kathleen Puntillo, RN, PhD

University of California, San Francisco

Phone: 415 819 2655

Email: kathleen.puntillo@ucsf.edu

Results disclosure agreements

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