Nitrous Oxide for Pain Management During In-office Transcervical Sterilization

NCT02312739 | Completed Results DMC

• 1 other identifier: UNMHSC13-594
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double blind study that aims to measure the difference in maximum pain experienced during in-office transcervical sterilization (Essure®) for women receiving either inhaled nitrous oxide or standard oral analgesia (Vicodin and Lorazepam) with inhaled oxygen. The investigators hypothesize that inhaled nitrous oxide will reduce the pain experienced more than standard oral medications in women undergoing in-office transcervical sterilization.

Conditions

Contraception; Inhalation of Nitrous Oxide

Keywords

pain assessment; pain measurement; patient satisfaction; anxiety; analgesia and anesthesia; female sterilization

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Pain Scale Measurement During and After the Procedure

  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.

  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)

• Pain Scale Measurement - Maximum Pain Experienced

  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.

  At 3-5 minutes after the procedure

Secondary Outcomes (3)

• Change From Baseline in Patient Anxiety Scale After the Procedure

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

• Patient Satisfaction (5-point Likert Scale)

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

• Provider Ease of Insertion (0-100mm VAS)

  Within 5 minutes after the Essure® procedure

Study Arms (2)

Vicodin, Lorazepam and Oxygen

ACTIVE COMPARATOR

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.

Procedure: In-office Transcervical Sterilization (Essure®); Drug: Standard Oral pain medications; Drug: Intramuscular Ketorolac; Other: Oxygen

Placebo pills and Nitrous Oxide

EXPERIMENTAL

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.

Procedure: In-office Transcervical Sterilization (Essure®); Drug: Intramuscular Ketorolac; Drug: Placebo pills; Other: Nitrous Oxide

Interventions

In-office Transcervical Sterilization (Essure®) PROCEDURE

The standard transcervical sterilization procedure is not being evaluated in this study, and will be performed in the same manner in the two study arms. The procedure includes a standardized paracervical block with 1% lidocaine. A 5mm operative hysteroscope is passed through the cervix and into the uterine cavity using normal saline for uterine distention. Each tubal ostium is identified, followed by deployment of the device into each fallopian tube. A confirmatory test, hysterosalpingogram, is required at 90 days post procedure to demonstrate successful sterilization.

Also known as: Essure®, Non-surgical permanent birth control, Transcervical sterilization, Hysteroscopic sterilization

Placebo pills and Nitrous Oxide; Vicodin, Lorazepam and Oxygen

Standard Oral pain medications DRUG

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

Also known as: Vicodin, Lorazepam

Vicodin, Lorazepam and Oxygen

Intramuscular Ketorolac DRUG

30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure

Also known as: IM ketorolac

Placebo pills and Nitrous Oxide; Vicodin, Lorazepam and Oxygen

Placebo pills DRUG

Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure

Also known as: Placebo

Placebo pills and Nitrous Oxide

Oxygen OTHER

Oxygen at 5L/min given to patients randomized to the active comparator arm

Also known as: O2

Vicodin, Lorazepam and Oxygen

Nitrous Oxide OTHER

Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm

Placebo pills and Nitrous Oxide

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Premenopausal women desiring permanent sterilization and have chosen to proceed with a transcervical sterilization approach
• Speaks English or Spanish
• If relying on state or federal funding for sterilization, must have appropriate federal consents signed 30 days prior to the sterilization procedure
• Agrees to either a hormonal endometrial preparation prior to the procedure or schedule the procedure during the follicular phase (days 5 through 12) of their menstrual cycle
• Sexually active who agrees to contraception for 3 months post procedure, including condoms, followed by a hysterosalpingogram (HSG) for confirmation of fallopian tubal occlusion.

You may not qualify if:

• With contraindications for nitrous oxide including: respiratory infection, chronic obstructive pulmonary disease (COPD), intoxication or use of street drugs, inability to breathe through their nose.
• Have taken narcotic pain medications prior to coming to their appointment
• Unsure about desire to end fertility
• History of pelvic inflammatory disease in the past 3 months
• Pregnancy or suspicion of pregnancy
• Delivery or termination of a pregnancy within the last 6 weeks
• Known allergy to contrast
• Uterine anomalies
• Previous tubal surgery
• Cervical or endometrial cancer
• Allergy to Vicodin, lorazepam, or lidocaine.

Sponsors & Collaborators

• University of New Mexico: lead
• Society of Family Planning: collaborator
• Bayer: collaborator

Study Sites (1)

UNM Center for Reproductive Health

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Patient Satisfaction; Anxiety Disorders; Agnosia

Interventions

acetaminophen, hydrocodone drug combination; Lorazepam; Oxygen; Nitrous Oxide

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chalcogens; Elements; Inorganic Chemicals; Gases; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds

Limitations and Caveats

Limitations of the study include the limited ability to truly blind physicians due to the signs and symptoms of N2O/O2 sedation being apparent.

Results Point of Contact

• Title: Sunderjeet Kaur
• Organization: Division of Family Planning, University of New Mexico

HSC-familyplanningresearch@salud.unm.edu

Email

Study Officials

• Rameet Singh, MD, MPH

  UNM OB GYN Division of Family Planning

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: December 9, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 6, 2016
• Results First Posted: July 6, 2016

Record last verified: 2016-05

Locations

US (1)