Nitrous Oxide for Pain Management of First Trimester Surgical Abortion

NCT02096575 | Completed Results DMC

• 1 other identifier: UNMHSC12-313
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to study the effect of nitrous oxide on pain felt by women having a surgical termination at less than 11 weeks compared to pain felt by women receiving oral pain medications.

Conditions

Abortion in First Trimester

Keywords

nitrous oxide; pain

Outcome Measures

Primary Outcomes (1)

• Visual Analog Pain Score for Mean Maximum Procedural Pain

  The primary outcome of this study is to evaluate the difference in mean maximum pain experienced during the procedure between groups as assessed 5 minutes after the procedure is completed. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain

  Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure

Secondary Outcomes (4)

• Visual Analog Scale Score for Baseline Pain

  Baseline pain assessment on average within 30 minutes before procedure

• Visual Analog Scale for Post-procedure Pain

  Visual analog scale administered on average 20 minutes after procedure completed

• Pain Management Satisfaction

  Visual analog scale for satisfaction administered on average within 20 minutes after procedure completion.

• Visual Analog Scale to Measure Anticipated Pain.

  Anticipated pain assessed on average within 30 minutes before procedure

Study Arms (2)

Nitrous oxide administration

EXPERIMENTAL

All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin. In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.

Other: Nitrous oxide administration

Standard care group

NO INTERVENTION

All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin. The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively.

Interventions

Nitrous oxide administration OTHER

All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. The NO group will get two placebo pills and the standard care group will get one 5/325 mg Vicodin, and 1 mg of Ativan 30 minutes before the procedure. The standard care group will get oxygen intraoperatively. NO or oxygen will be administered via a scented nasal mask to blind patients to the intervention. All patients will get local anesthesia via a standardized PCB.

Nitrous oxide administration

Eligibility Criteria

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

You may qualify if:

• years old or older,
• elective pregnancy termination at gestational age of less than 11 weeks,
• speak English
• candidate for an in-clinic procedure.
• desire local anesthesia, ibuprofen, Vicodin and Ativan (the usual treatment in our clinic) for managing pain

You may not qualify if:

• no medical problems preventing the use of nitrous oxide
• no allergies to nitrous oxide, lidocaine, vasopressin, ibuprofen, Vicodin or Ativan
• significant active upper respiratory infection
• chronic obstructive pulmonary disease (COPD)
• intoxication
• use of street drugs

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

• Singh RH, Espey E, Carr S, Pereda B, Ogburn T, Leeman L. Nitrous oxide for pain management of first trimester surgical abortion -- a randomized controlled pilot study. Contraception. 2015 Feb;91(2):164-6. doi: 10.1016/j.contraception.2014.09.013. Epub 2014 Oct 22.

  PMID: 25459096 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michel Paves, HS Research Specialist
• Organization: U of New Mexico - Dept of OBGYN/Family Planning

MDaliva@salud.unm.edu

505-272-9703

Study Officials

• Rameet H. Singh, MD, MPH

  University of New Mexico Health Sciences Center

  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
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 26, 2014
• Study Start: August 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 19, 2016
• Results First Posted: March 11, 2016

Record last verified: 2016-04

Locations

US (1)