Trial Outcomes & Findings for Anesthesia and Postoperative Pain (NCT NCT00232817)

Results Overview

Pain was reported on the Numerical Rating Scale for pain (NRS) with 0=no pain and 10=worst pain. Pain was assessed at 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 120, and 1440 minutes post-op, and the average of all time-points is reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

Up to 24 hours

Results posted on

2024-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Nicotine Patients were administered anesthetic (1-2 μg/kg fentanyl and 1 mg vecuronium) before surgery. After surgery, patients were administered with a nicotine nasal spray (3 mg Nicotrol).	Placebo Patients were administered anesthetic (1-2 μg/kg fentanyl and 1 mg vecuronium) before surgery. After surgery, patients were administered with a saline nasal spray.
Overall Study STARTED	12	11
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Nicotine Patients were administered anesthetic (1-2 μg/kg fentanyl and 1 mg vecuronium) before surgery. After surgery, patients were administered with a nicotine nasal spray (3 mg Nicotrol).	Placebo Patients were administered anesthetic (1-2 μg/kg fentanyl and 1 mg vecuronium) before surgery. After surgery, patients were administered with a saline nasal spray.
Overall Study Protocol Violation	2	1

Baseline Characteristics

no difference

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment - Nicotine n=10 Participants Nicotine nasal spray	Treatment - Placebo n=10 Participants Placebo	Total n=20 Participants Total of all reporting groups
Age, Continuous	43.0 years STANDARD_DEVIATION 9.2 • n=5 Participants	46.1 years STANDARD_DEVIATION 6.9 • n=7 Participants	44.6 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Weight	143.5 pounds STANDARD_DEVIATION 37.0 • n=5 Participants • no difference	146.3 pounds STANDARD_DEVIATION 29.0 • n=7 Participants • no difference	145.0 pounds STANDARD_DEVIATION 32.4 • n=5 Participants • no difference

PRIMARY outcome

Timeframe: Up to 24 hours

Pain was reported on the Numerical Rating Scale for pain (NRS) with 0=no pain and 10=worst pain. Pain was assessed at 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 120, and 1440 minutes post-op, and the average of all time-points is reported.

Outcome measures

Outcome measures
Measure	Nicotine n=10 Participants Patients were administered anesthetic (1-2 μg/kg fentanyl and 1 mg vecuronium) before surgery. After surgery, patients were administered with a nicotine nasal spray (3 mg Nicotrol).	Placebo n=10 Participants Patients were administered anesthetic (1-2 μg/kg fentanyl and 1 mg vecuronium) before surgery. After surgery, patients were administered with a saline nasal spray.
Score on a Pain Rating Scale (Numerical Analog Score)	1.5 scores on a scale Standard Deviation 0.5	4.9 scores on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Up to 24 hours

The amount of morphine used by each patient at the following time points will be summed: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 120, and 1440 minutes post-operative. A patient-controlled analgesia pump was programmed to deliver a dose of 1 mg morphine when the button is pressed with a lockout interval of 6 min and a maximal dose during 1 h of 10 mg. The pump is also programmed to allow a rescue dose of 3mg morphine to be administered by a nurse every 5 min with additional 12 mg morphine maximally by this route every 4 hours. A patient could receive 24 mg of morphine as a maximal dose in the first hour.

Outcome measures

Outcome measures
Measure	Nicotine n=10 Participants Patients were administered anesthetic (1-2 μg/kg fentanyl and 1 mg vecuronium) before surgery. After surgery, patients were administered with a nicotine nasal spray (3 mg Nicotrol).	Placebo n=10 Participants Patients were administered anesthetic (1-2 μg/kg fentanyl and 1 mg vecuronium) before surgery. After surgery, patients were administered with a saline nasal spray.
Cumulative Morphine Usage	35.3 mg Standard Deviation 23.7	51.6 mg Standard Deviation 26.6

Adverse Events

Nicotine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Pamela Flood

Columbia University

Phone: 201-370-3933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place