Trial Outcomes & Findings for Nitrous Oxide for Pain Management of Intrauterine Device (IUD) Insertion (NCT NCT02391714)
NCT ID: NCT02391714
Last Updated: 2016-02-03
Results Overview
Pain is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. The minimal clinically important difference in pain for this study was set at 15mm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
2 minutes after the procedure.
Results posted on
2016-02-03
Participant Flow
Participant milestones
| Measure |
Oxygen (Placebo)
100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Oxygen: 100% oxygen via nasal mask.
|
Nitrous Oxide (NO)
Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nitrous Oxide for Pain Management of Intrauterine Device (IUD) Insertion
Baseline characteristics by cohort
| Measure |
Oxygen (Placebo)
n=40 Participants
100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Oxygen: 100% oxygen via nasal mask.
|
Nitrous Oxide (NO)
n=40 Participants
Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.3 years
n=5 Participants
|
24.93 years
n=7 Participants
|
25.62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 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
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 minutes after the procedure.Pain is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. The minimal clinically important difference in pain for this study was set at 15mm.
Outcome measures
| Measure |
Oxygen (Placebo)
n=40 Participants
100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Oxygen: 100% oxygen via nasal mask.
|
Nitrous Oxide (NO)
n=40 Participants
Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask.
|
|---|---|---|
|
Mean Maximum Procedural Pain Scores
|
55.3 units on a scale
Standard Deviation 20.9
|
54.3 units on a scale
Standard Deviation 24.8
|
SECONDARY outcome
Timeframe: Prior to clinic discharge, which is an average of 15 minutes after the procedureSatisfaction will be measured using a 100mm Visual Analog Scale (VAS), with anchors 0mm for very satisfied and 100mm for very dissatisfied.
Outcome measures
| Measure |
Oxygen (Placebo)
n=40 Participants
100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Oxygen: 100% oxygen via nasal mask.
|
Nitrous Oxide (NO)
n=40 Participants
Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask.
|
|---|---|---|
|
Patient Satisfaction With Over-all Pain Control With IUD Insertion - VAS
|
60.3 units on a scale
Standard Deviation 26.6
|
66.0 units on a scale
Standard Deviation 32.2
|
SECONDARY outcome
Timeframe: Before the IUD insertion procedureBaseline pain scores prior to IUD insertion is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. The minimal clinically important difference in pain for this study was set at 15mm.
Outcome measures
| Measure |
Oxygen (Placebo)
n=40 Participants
100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Oxygen: 100% oxygen via nasal mask.
|
Nitrous Oxide (NO)
n=40 Participants
Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask.
|
|---|---|---|
|
Baseline Mean Pain Scores
|
1.9 units on a scale
Standard Deviation 4.6
|
2.4 units on a scale
Standard Deviation 4.1
|
Adverse Events
Oxygen (Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nitrous Oxide (NO)
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
Sunderjeet Kaur
Division of Family Planning, University of New Mexico
Phone: Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place