Trial Outcomes & Findings for Nitrous Oxide for Pain Management During In-office Transcervical Sterilization (NCT NCT02312739)

Last Updated: 2016-07-06

Results Overview

Pain is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. It is taken at baseline, after paracervical block injection and after placement of second Essure® coil. A final pain assessment is done prior to discharge.

Recruitment status

COMPLETED

Study phase

Target enrollment

72 participants

Primary outcome timeframe

At baseline before the procedure, during the procedure after paracervical block injection and after placement of second Essure® coil, and prior to discharge from clinic (approximately 30-45 minutes postprocedure)

Results posted on

2016-07-06

Participant Flow

Participant milestones

Participant milestones
Measure	Vicodin, Lorazepam and Oxygen Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given. All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique. Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm	Placebo Pills and Nitrous Oxide Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask. All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique. Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm
Overall Study STARTED	36	36
Overall Study Withdrawn Prior to Procedure	6	2
Overall Study COMPLETED	30	34
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nitrous Oxide for Pain Management During In-office Transcervical Sterilization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vicodin, Lorazepam and Oxygen n=30 Participants Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given. All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique. Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm	Placebo Pills and Nitrous Oxide n=34 Participants Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask. All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique. Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm	Total n=64 Participants Total of all reporting groups
Age, Continuous	34.6 years STANDARD_DEVIATION 6.6 • n=5 Participants	33.6 years STANDARD_DEVIATION 4.9 • n=7 Participants	34.1 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	34 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	13 participants n=5 Participants	9 participants n=7 Participants	22 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Mexican/Spanish	14 participants n=5 Participants	16 participants n=7 Participants	30 participants n=5 Participants
Race/Ethnicity, Customized Native American/Alaska native	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized More than one	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Unknown	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	34 participants n=7 Participants	64 participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline before the procedure, during the procedure after paracervical block injection and after placement of second Essure® coil, and prior to discharge from clinic (approximately 30-45 minutes postprocedure)

Outcome measures

Outcome measures
Measure	Vicodin, Lorazepam and Oxygen n=30 Participants Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given. All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique. Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm	Placebo Pills and Nitrous Oxide n=34 Participants Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask. All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique. Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm
Change From Baseline in Pain Scale Measurement During and After the Procedure Baseline Pain	1.1 units on a scale Standard Deviation 3.2	2.5 units on a scale Standard Deviation 6.7
Change From Baseline in Pain Scale Measurement During and After the Procedure After Parcervical Block	15.6 units on a scale Standard Deviation 22.2	15.4 units on a scale Standard Deviation 24.3
Change From Baseline in Pain Scale Measurement During and After the Procedure At Second Coil Placement	40.7 units on a scale Standard Deviation 33.5	14.9 units on a scale Standard Deviation 23.6
Change From Baseline in Pain Scale Measurement During and After the Procedure Pain at Clinic Discharge	20.4 units on a scale Standard Deviation 21.9	12.4 units on a scale Standard Deviation 15.8

PRIMARY outcome

Timeframe: At 3-5 minutes after the procedure

The maximum pain that was experienced during the procedure is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. It is taken at 3 to 5 minutes following completion of the procedure.

Outcome measures

Outcome measures
Measure	Vicodin, Lorazepam and Oxygen n=30 Participants Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given. All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique. Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm	Placebo Pills and Nitrous Oxide n=34 Participants Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask. All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique. Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm
Pain Scale Measurement - Maximum Pain Experienced	54.5 units on a scale Standard Deviation 32.7	22.8 units on a scale Standard Deviation 27.6

SECONDARY outcome

Timeframe: At baseline before the procedure and at 3-5 minutes after the Essure® procedure

Participants were asked to complete a validated short form of the Spielberger State-Trait Anxiety Inventory (STAI) at baseline and at 3-5 minutes after the in-office sterilization procedure. On the STAI scale, participants rated five statements (I feel calm, I am tense, I feel upset, I am relaxed, I am worried) on a 1 - 4 scale (Not at all, Somewhat, Moderately, Very Much, totaling in a score from 0-20 (0 being least anxious, 20 being the most anxious).

Outcome measures

Outcome measures
Measure	Vicodin, Lorazepam and Oxygen n=30 Participants Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given. All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique. Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm	Placebo Pills and Nitrous Oxide n=34 Participants Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask. All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique. Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm
Change From Baseline in Patient Anxiety Scale After the Procedure Pre-procedure	8.4 units on a scale Standard Deviation 2.7	9.4 units on a scale Standard Deviation 2.9
Change From Baseline in Patient Anxiety Scale After the Procedure Post-procedure	8.5 units on a scale Standard Deviation 2.9	8.2 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: Prior to discharge from clinic, approximately 30-45 minutes post-procedure

Patients were asked to rate their overall satisfaction with the procedure using a 5-point Likert scale (Very unsatisfied, Unsatisfied, Neutral, Satisfied, Very satisfied). Results were analyzed to portray the percentage of participants who felt satisfied at the listed interval levels.

Outcome measures

Outcome measures
Measure	Vicodin, Lorazepam and Oxygen n=30 Participants Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given. All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique. Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm	Placebo Pills and Nitrous Oxide n=34 Participants Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask. All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique. Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm
Patient Satisfaction (5-point Likert Scale) Very satisfied/satisfied with pain management	77 percentage of participants	85 percentage of participants
Patient Satisfaction (5-point Likert Scale) Neutral, unsatisfied or very unsatisfied	23 percentage of participants	15 percentage of participants

SECONDARY outcome

Timeframe: Within 5 minutes after the Essure® procedure

Physician who did the procedure will complete a 0-100mm VAS on ease of insertion of the sterilization devices with anchors 0 equals no difficulty and 100 equals very difficult.

Outcome measures

Outcome measures
Measure	Vicodin, Lorazepam and Oxygen n=30 Participants Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given. All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique. Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm	Placebo Pills and Nitrous Oxide n=34 Participants Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask. All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique. Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm
Provider Ease of Insertion (0-100mm VAS)	22.7 units on a scale Standard Deviation 24.8	19.8 units on a scale Standard Deviation 20.7

Adverse Events

Vicodin, Lorazepam and Oxygen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Pills and Nitrous Oxide

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