Trial Outcomes & Findings for Inhaled Nitrous Oxide and Labor Analgesia (NCT NCT01738672)
NCT ID: NCT01738672
Last Updated: 2017-11-21
Results Overview
Participant reported pain score, using a numerical rating scale (NRS) ranging from no pain (0) to severe pain (10).
TERMINATED
PHASE2
16 participants
At baseline, and at 1 hour after initiation of nitrous oxide
2017-11-21
Participant Flow
Participant milestones
| Measure |
Nitrous Oxide
Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.
Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inhaled Nitrous Oxide and Labor Analgesia
Baseline characteristics by cohort
| Measure |
Nitrous Oxide
n=16 Participants
Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.
Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia
|
|---|---|
|
Age, Continuous
|
30 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline, and at 1 hour after initiation of nitrous oxidePopulation: Data are included for all participants from which they were collected.
Participant reported pain score, using a numerical rating scale (NRS) ranging from no pain (0) to severe pain (10).
Outcome measures
| Measure |
Nitrous Oxide
n=16 Participants
Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.
Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia
|
|---|---|
|
Labor Pain
Baseline
|
8.88 units on a scale
Standard Deviation 0.97
|
|
Labor Pain
1 hour after initiation of nitrous oxide
|
8.18 units on a scale
Standard Deviation 1.72
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline, and at 1 hour after initiation of nitrous oxidePopulation: Data are included for all participants from which they were collected.
Participant reported anxiety score, using a numerical rating scale (NRS) ranging from no anxiety (0) to severe anxiety (10).
Outcome measures
| Measure |
Nitrous Oxide
n=15 Participants
Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.
Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia
|
|---|---|
|
Anxiety
Baseline
|
2.50 units on a scale
Standard Deviation 3.54
|
|
Anxiety
1 hour after initiation of nitrous oxide
|
2.00 units on a scale
Standard Deviation 3.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline, and at 1 hour after initiation of nitrous oxidePopulation: Data are included for all participants from which they were collected.
Participant reported nausea score, using a numerical rating scale (NRS) ranging from no nausea (0) to severe nausea (10).
Outcome measures
| Measure |
Nitrous Oxide
n=16 Participants
Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.
Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia
|
|---|---|
|
Nausea
Baseline
|
0.25 units on a scale
Standard Deviation 0.58
|
|
Nausea
1 hour after initiation of nitrous oxide
|
0.46 units on a scale
Standard Deviation 1.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During administration of nitrous oxidePopulation: Data are included for all participants from which they were collected.
Participant reported emesis (yes or no).
Outcome measures
| Measure |
Nitrous Oxide
n=16 Participants
Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.
Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia
|
|---|---|
|
Emesis
|
1 participants experiencing emesis
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hours after deliveryPopulation: Data are included for all participants from which they were collected.
Participant reported score of satisfaction with nitrous oxide for labor analgesia, using a numerical rating scale (NRS) ranging from completely dissatisfied (0) to completely satisfied (100).
Outcome measures
| Measure |
Nitrous Oxide
n=3 Participants
Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.
Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia
|
|---|---|
|
Participant Satisfaction
|
90 units on a scale
Interval 85.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Initiation of nitrous oxide to completion of delivery.Population: Data are included for all participants from which they were collected.
Participants crossing over from nitrous oxide to epidural.
Outcome measures
| Measure |
Nitrous Oxide
n=15 Participants
Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.
Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia
|
|---|---|
|
Crossover To Epidural
|
8 participants
|
Adverse Events
Nitrous Oxide
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nitrous Oxide
n=16 participants at risk
Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.
Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia
|
|---|---|
|
General disorders
Pain
|
100.0%
16/16
|
|
Psychiatric disorders
Anxiety
|
43.8%
7/16
|
|
Gastrointestinal disorders
Nausea
|
18.8%
3/16
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16
|
|
Cardiac disorders
Sinus Bradycardia
|
6.2%
1/16
|
|
Cardiac disorders
Sinus Tachycardia
|
18.8%
3/16
|
|
Vascular disorders
Hypertension
|
12.5%
2/16
|
|
Vascular disorders
Hypotension
|
18.8%
3/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place