Inhaled Nitrous Oxide and Labor Analgesia
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|ClinicalTrials.gov Identifier: NCT01738672|
Recruitment Status : Terminated
First Posted : November 30, 2012
Results First Posted : November 21, 2017
Last Update Posted : November 21, 2017
Hypothesis: The administration of nitrous oxide for labor analgesia will decrease the labor epidural anesthesia rate by 15%.
Specific Aim: To determine if nitrous oxide can be an effective alternative technique for the provision of labor analgesia at Magee-Womens Hospital.
|Condition or disease||Intervention/treatment||Phase|
|Labor Pain||Drug: Inhaled nitrous oxide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Inhaled Nitrous Oxide and Labor Analgesia|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Nitrous Oxide
Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.
Drug: Inhaled nitrous oxide
Administration of nitrous oxide for labor analgesia
- Labor Pain [ Time Frame: At baseline, and at 1 hour after initiation of nitrous oxide ]Participant reported pain score, using a numerical rating scale (NRS) ranging from no pain (0) to severe pain (10).
- Anxiety [ Time Frame: At baseline, and at 1 hour after initiation of nitrous oxide ]Participant reported anxiety score, using a numerical rating scale (NRS) ranging from no anxiety (0) to severe anxiety (10).
- Nausea [ Time Frame: At baseline, and at 1 hour after initiation of nitrous oxide ]Participant reported nausea score, using a numerical rating scale (NRS) ranging from no nausea (0) to severe nausea (10).
- Emesis [ Time Frame: During administration of nitrous oxide ]Participant reported emesis (yes or no).
- Participant Satisfaction [ Time Frame: 24 hours after delivery ]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).
- Crossover To Epidural [ Time Frame: Initiation of nitrous oxide to completion of delivery. ]Participants crossing over from nitrous oxide to epidural.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738672
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Ya'aqov Abrams, MD||University of Pittsburgh|