Trial Outcomes & Findings for A Non-inferiority Trial on Pain Relief During Oocyte Retrieval (NCT NCT02494180)
NCT ID: NCT02494180
Last Updated: 2019-03-05
Results Overview
The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
170 participants
Primary outcome timeframe
will be assessed within 4 hours of oocyte retrieval
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
A: Intravenous Fentanyl, Midazolam
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
fentanyl: arm A receiving iv fentanyl
Midazolam: arm A receiving iv midazolam
|
B: Intravenous Pethidine, Diazepam
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
pethidine: arm B receiving iv pethidine
Diazepam: arm B receiving iv diazepam
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
85
|
|
Overall Study
COMPLETED
|
85
|
85
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Non-inferiority Trial on Pain Relief During Oocyte Retrieval
Baseline characteristics by cohort
| Measure |
A: Intravenous Fentanyl, Midazolam
n=85 Participants
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
fentanyl: arm A receiving iv fentanyl
Midazolam: arm A receiving iv midazolam
|
B: Intravenous Pethidine, Diazepam
n=85 Participants
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
pethidine: arm B receiving iv pethidine
Diazepam: arm B receiving iv diazepam
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=99 Participants
|
37 years
n=107 Participants
|
37 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
170 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
170 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Hong Kong
|
85 participants
n=99 Participants
|
85 participants
n=107 Participants
|
170 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: will be assessed within 4 hours of oocyte retrievalThe pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful
Outcome measures
| Measure |
A: Intravenous Fentanyl, Midazolam
n=85 Participants
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
fentanyl: arm A receiving iv fentanyl
Midazolam: arm A receiving iv midazolam
|
B: Intravenous Pethidine, Diazepam
n=85 Participants
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
pethidine: arm B receiving iv pethidine
Diazepam: arm B receiving iv diazepam
|
|---|---|---|
|
Pain Level During Oocyte Retrieval
vaginal pain
|
0 score on a scale
Interval 0.0 to 2.5
|
4 score on a scale
Interval 1.0 to 7.0
|
|
Pain Level During Oocyte Retrieval
abdominal pain
|
2.5 score on a scale
Interval 0.0 to 5.0
|
5 score on a scale
Interval 2.5 to 7.5
|
PRIMARY outcome
Timeframe: will be assessed within 4 hours of oocyte retrievalThe pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful
Outcome measures
| Measure |
A: Intravenous Fentanyl, Midazolam
n=85 Participants
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
fentanyl: arm A receiving iv fentanyl
Midazolam: arm A receiving iv midazolam
|
B: Intravenous Pethidine, Diazepam
n=85 Participants
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
pethidine: arm B receiving iv pethidine
Diazepam: arm B receiving iv diazepam
|
|---|---|---|
|
Pain Level After Oocyte Retrieval
vaginal pain
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 2.5
|
|
Pain Level After Oocyte Retrieval
abdominal pain
|
2.3 score on a scale
Interval 0.0 to 2.8
|
2 score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: will be assessed within 4 hours of oocyte retrievalside effects will be scored by yes or no
Outcome measures
| Measure |
A: Intravenous Fentanyl, Midazolam
n=85 Participants
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
fentanyl: arm A receiving iv fentanyl
Midazolam: arm A receiving iv midazolam
|
B: Intravenous Pethidine, Diazepam
n=85 Participants
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
pethidine: arm B receiving iv pethidine
Diazepam: arm B receiving iv diazepam
|
|---|---|---|
|
Percentage of Participants With Side Effects by Type
nausea
|
2.4 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants With Side Effects by Type
vomiting
|
0 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Side Effects by Type
dizziness
|
16.5 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants With Side Effects by Type
drowsiness
|
8.2 percentage of participants
|
3.5 percentage of participants
|
|
Percentage of Participants With Side Effects by Type
shortness of breath
|
0 percentage of participants
|
1.2 percentage of participants
|
SECONDARY outcome
Timeframe: will be assessed within 4 hours of oocyte retrievalsatisfaction will be scored from 0-3 (0=excellent, 1=satisfactory, 2=fair, 3=unsatisfactory)
Outcome measures
| Measure |
A: Intravenous Fentanyl, Midazolam
n=85 Participants
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
fentanyl: arm A receiving iv fentanyl
Midazolam: arm A receiving iv midazolam
|
B: Intravenous Pethidine, Diazepam
n=85 Participants
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
pethidine: arm B receiving iv pethidine
Diazepam: arm B receiving iv diazepam
|
|---|---|---|
|
Patient's Satisfaction on Oocyte Retrieval
excellent
|
47.7 percentage of participants
|
15.3 percentage of participants
|
|
Patient's Satisfaction on Oocyte Retrieval
satisfactory
|
38.8 percentage of participants
|
55.3 percentage of participants
|
|
Patient's Satisfaction on Oocyte Retrieval
fair
|
11.8 percentage of participants
|
22.4 percentage of participants
|
|
Patient's Satisfaction on Oocyte Retrieval
unsatisfactory
|
4.7 percentage of participants
|
7.1 percentage of participants
|
SECONDARY outcome
Timeframe: will be assessed within ten weeks of oocyte retrievalpresence of intrauterine sac in ultrasound after a positive pregnancy test
Outcome measures
| Measure |
A: Intravenous Fentanyl, Midazolam
n=85 Participants
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
fentanyl: arm A receiving iv fentanyl
Midazolam: arm A receiving iv midazolam
|
B: Intravenous Pethidine, Diazepam
n=85 Participants
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
pethidine: arm B receiving iv pethidine
Diazepam: arm B receiving iv diazepam
|
|---|---|---|
|
Clinical Pregnancy Rate
|
14.1 percentage of participants
|
23.5 percentage of participants
|
SECONDARY outcome
Timeframe: will be assessed within ten weeks of oocyte retrievalpositive fetal heart pulsation seen in ultrasound at eight weeks of gestation
Outcome measures
| Measure |
A: Intravenous Fentanyl, Midazolam
n=85 Participants
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
fentanyl: arm A receiving iv fentanyl
Midazolam: arm A receiving iv midazolam
|
B: Intravenous Pethidine, Diazepam
n=85 Participants
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
pethidine: arm B receiving iv pethidine
Diazepam: arm B receiving iv diazepam
|
|---|---|---|
|
Ongoing Pregnancy Rate
|
12.9 percentage of participants
|
21.2 percentage of participants
|
SECONDARY outcome
Timeframe: within 4 hours after retrievalsatisfaction on pain relief will be scored at 0-10 (10 being most satisfied)
Outcome measures
| Measure |
A: Intravenous Fentanyl, Midazolam
n=85 Participants
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
fentanyl: arm A receiving iv fentanyl
Midazolam: arm A receiving iv midazolam
|
B: Intravenous Pethidine, Diazepam
n=85 Participants
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
pethidine: arm B receiving iv pethidine
Diazepam: arm B receiving iv diazepam
|
|---|---|---|
|
Patient's Satisfaction on Pain Relief
|
8 score on a scale
Interval 7.0 to 10.0
|
7 score on a scale
Interval 6.0 to 9.0
|
SECONDARY outcome
Timeframe: immediately after retrievalS = sleeping, easily aroused; 1 = awake and alert; 2 = occasionally drowsy, easy to arouse; 3 = frequently drowsy, arousable, drifts off to sleep during conversation; 4 = somnolent, minimal or no response to stimuli
Outcome measures
| Measure |
A: Intravenous Fentanyl, Midazolam
n=85 Participants
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
fentanyl: arm A receiving iv fentanyl
Midazolam: arm A receiving iv midazolam
|
B: Intravenous Pethidine, Diazepam
n=85 Participants
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
pethidine: arm B receiving iv pethidine
Diazepam: arm B receiving iv diazepam
|
|---|---|---|
|
Sedation Level
2
|
14 Participants
|
17 Participants
|
|
Sedation Level
3
|
16 Participants
|
4 Participants
|
|
Sedation Level
4
|
21 Participants
|
5 Participants
|
|
Sedation Level
S
|
18 Participants
|
7 Participants
|
|
Sedation Level
missing data
|
1 Participants
|
0 Participants
|
|
Sedation Level
1
|
15 Participants
|
52 Participants
|
Adverse Events
A: Intravenous Fentanyl, Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B: Intravenous Pethidine, Diazepam
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place