Trial Outcomes & Findings for Analgesic Effect of Peripheral Dexmedetomidine (NCT NCT00971178)

NCT ID: NCT00971178

Last Updated: 2020-12-11

Results Overview

The Numerical Rating Scale (NRS) is used for pain score assessment at rest. It is a scale consists of 11 numbers in which 0 corresponds to no pain and 10 represents the worst pain imaginable. The NRS pain scores over postoperative 72 hours is expressed as Area Under Curve using the trapezoid rule and compared among the 3 groups using the Kruskal-Wallis test.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 105 participants
• Primary outcome timeframe: 72 hours after surgery
• Results posted on: 2020-12-11

Participant Flow

Patients undergoing bilateral third molar surgery under general anesthesia in Queen Mary Hospital were recruited.

The patients were assessed by the scheduled anesthesiologist the day before surgery, were fasted for at least 6 hours and did not receive any premedication before arrival at the operation room.

Participant milestones

Measure	Local Dexmedetomidine Given intravenous 0.9% saline before incision and dexmedetomidine (1 mg/mL) infiltrated to the 4 surgical wound sites at the end of surgery.	Normal Saline 0.9% saline given intravenously before incision and infiltrated at the end of surgery to the 4 wound sites.	IV Dexmedetomidine Given intravenous dexmedetomidine (1 mg/kg), infused over 10 minutes before incision and 0.9% saline infiltrated to 4 surgical wound sites at the end of the surgery.
Overall Study STARTED	35	35	35
Overall Study COMPLETED	33	33	33
Overall Study NOT COMPLETED	2	2	2

Reasons for withdrawal

Measure	Local Dexmedetomidine Given intravenous 0.9% saline before incision and dexmedetomidine (1 mg/mL) infiltrated to the 4 surgical wound sites at the end of surgery.	Normal Saline 0.9% saline given intravenously before incision and infiltrated at the end of surgery to the 4 wound sites.	IV Dexmedetomidine Given intravenous dexmedetomidine (1 mg/kg), infused over 10 minutes before incision and 0.9% saline infiltrated to 4 surgical wound sites at the end of the surgery.
Overall Study Lost to Follow-up	2	2	2

Baseline Characteristics

Analgesic Effect of Peripheral Dexmedetomidine

Baseline characteristics by cohort

Measure	Local Dexmedetomidine n=33 Participants local dexmedetomidine: Preoperative normal saline infusion and 1mcg/kg dexmedetomidine infiltrated locally to wound at the end of operation.	Normal Saline n=33 Participants Peripheral normal saline: Same volume of normal saline as dexmedetomidine is infiltrated and IV infusion.	IV Dexmedetomidine n=33 Participants IV dexmedetomidine: IV dexmedetomidine 1mcg/kg peroperative and normal saline infiltrated to wound at the end of operation	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=93 Participants	33 Participants n=4 Participants	33 Participants n=27 Participants	99 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	27.0 years STANDARD_DEVIATION 6.9 • n=93 Participants	24.0 years STANDARD_DEVIATION 4.7 • n=4 Participants	24.7 years STANDARD_DEVIATION 5.1 • n=27 Participants	25.2 years STANDARD_DEVIATION 5.6 • n=483 Participants
Sex: Female, Male Female	18 Participants n=93 Participants	20 Participants n=4 Participants	18 Participants n=27 Participants	56 Participants n=483 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	13 Participants n=4 Participants	15 Participants n=27 Participants	43 Participants n=483 Participants
Region of Enrollment Hong Kong	33 Participants n=93 Participants	33 Participants n=4 Participants	33 Participants n=27 Participants	99 Participants n=483 Participants

PRIMARY outcome

Timeframe: 72 hours after surgery

The Numerical Rating Scale (NRS) is used for pain score assessment at rest. It is a scale consists of 11 numbers in which 0 corresponds to no pain and 10 represents the worst pain imaginable. The NRS pain scores over postoperative 72 hours is expressed as Area Under Curve using the trapezoid rule and compared among the 3 groups using the Kruskal-Wallis test.

Outcome measures

Measure	Local Dexmedetomidine n=33 Participants Given intravenous 0.9% saline before incision and dexmedetomidine (1 mg/mL) infiltrated to the 4 surgical wound sites at the end of surgery.	Normal Saline n=33 Participants 0.9% saline given intravenously before incision and infiltrated at the end of surgery to the 4 wound sites.	IV Dexmedetomidine n=33 Participants Given intravenous dexmedetomidine (1 mg/kg), infused over 10 minutes before incision and 0.9% saline infiltrated to 4 surgical wound sites at the end of the surgery.
Pain Score at Rest	165.5 score on a scale×hr Standard Deviation 133.0	218.2 score on a scale×hr Standard Deviation 132.9	233.8 score on a scale×hr Standard Deviation 153.1

POST_HOC outcome

Timeframe: From time 0 （End From time 0 (end of surgery) to 72 hours after surgery

Amount of oral analgesic is recorded for postoperative period until 72 hours. The amount is recorded as number of tablets.

Outcome measures

Outcome data not reported

Adverse Events

Local Dexmedetomidine

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

IV Dexmedetomidine

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Local Dexmedetomidine n=33 participants at risk Intravenous 0.9% saline before incision and dexmedetomidine (1 mg/mL) infiltrated to the 4 surgical wound sites at the end of surgery.	Normal Saline n=33 participants at risk Intravenous 0.9% saline before incision and 0.9% saline infiltrated at the end of surgery to the 4 wound sites.	IV Dexmedetomidine n=33 participants at risk Intravenous dexmedetomidine (1 mg/kg), infused over 10 minutes before incision and 0.9% saline infiltrated to 4 surgical wound sites at the end of the surgery.
General disorders Nausea	3.0% 1/33 • Number of events 1 • 1 day after surgery	12.1% 4/33 • Number of events 4 • 1 day after surgery	24.2% 8/33 • Number of events 8 • 1 day after surgery
General disorders Dizziness	45.5% 15/33 • Number of events 15 • 1 day after surgery	60.6% 20/33 • Number of events 20 • 1 day after surgery	57.6% 19/33 • Number of events 19 • 1 day after surgery
General disorders tiredness	54.5% 18/33 • Number of events 18 • 1 day after surgery	33.3% 11/33 • Number of events 11 • 1 day after surgery	69.7% 23/33 • Number of events 23 • 1 day after surgery
General disorders Headache	21.2% 7/33 • Number of events 7 • 1 day after surgery	27.3% 9/33 • Number of events 9 • 1 day after surgery	39.4% 13/33 • Number of events 13 • 1 day after surgery
General disorders Agitation in recovery area	9.1% 3/33 • Number of events 3 • 1 day after surgery	30.3% 10/33 • Number of events 10 • 1 day after surgery	30.3% 10/33 • Number of events 10 • 1 day after surgery
General disorders Dry mouth	51.5% 17/33 • Number of events 17 • 1 day after surgery	45.5% 15/33 • Number of events 15 • 1 day after surgery	42.4% 14/33 • Number of events 14 • 1 day after surgery
General disorders Wound infection	3.0% 1/33 • Number of events 1 • 1 day after surgery	9.1% 3/33 • Number of events 3 • 1 day after surgery	0.00% 0/33 • 1 day after surgery

Additional Information

Clinical Assistant Professor

Department of Anaesthesiology, the University of Hong Kong

Phone: 852-22553303

Email: cheucw@hku.hk

Results disclosure agreements

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