Nitrous Oxide for Pain Management of First Trimester Surgical Abortion

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Abortion in First Trimester

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nitrous oxide administration

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.

Group Type EXPERIMENTAL

Nitrous oxide administration

Intervention Type 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.

Standard care group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nitrous oxide administration

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes