Nitrous Oxide for Pain Management of First Trimester Surgical Abortion (NAB)

University of New Mexico (UNM)

Status: Completed

Conditions: Abortion in First Trimester

Treatments: Other: Nitrous oxide administration

Study type: Interventional

Funder types: Other

Identifiers

NCT02096575

UNMHSC12-313

Details and patient eligibility

About

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.

Full description

This study has important implications in the field of pain management for surgical abortion. While NO is administered in some outpatient clinics for surgical abortion, its effect on pain has not been systematically studied in a randomized controlled trial in women undergoing first trimester surgical abortion under local/oral analgesia. Expanding pain management options for women undergoing abortion confers significant public health benefits.

Enrollment: 140 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 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

Exclusion criteria

• 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

Trial design

140 participants in 2 patient groups

Nitrous oxide administration

Experimental group

Description:

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.

Treatment:

Other: Nitrous oxide administration

Standard care group

No Intervention group

Description:

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.