Spontaneous Abortion Clinical Trial
— GABAOfficial title:
Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration: a Randomized Controlled Trial
Verified date | June 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized controlled double-blind placebo-controlled trial evaluating the impact of gabapentin given preoperatively on perioperative pain scores for women receiving uterine aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the abortion setting.
Status | Completed |
Enrollment | 96 |
Est. completion date | June 14, 2018 |
Est. primary completion date | June 13, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Women >=18 years-old - Presenting for a surgical abortion - No contraindication to outpatient abortion - No contraindication to gabapentin - Fluency in English and able to provide informed consent Exclusion Criteria: - Allergy, sensitivity or contraindication to gabapentin - Severe renal disease - Currently using gabapentin or pregalabin |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure | Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life. | 5 minutes | |
Secondary | Pain Score on the 100-mm VAS | Measured at baseline, 10 minutes post-procedure, and 30 minutes post-procedure. Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life. | Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute | |
Secondary | Perioperative Nausea as Measured by 100-mm VAS | Score range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life. | Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes | |
Secondary | Number of Subjects Experiencing Perioperative Vomiting | Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes | ||
Secondary | Perioperative Anxiety as Measured by the 100-mm VAS | Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious. | 5 minutes, 10 minutes, 30 minutes, discharge | |
Secondary | Number of Subjects Using Pain Medications | Pain medications included ibuprofen and oxycodone. | 24 hours post-operatively | |
Secondary | Number of Subjects Experiencing Side Effects | Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia. | 10 minutes post-procedure | |
Secondary | Pain (on a 5-point Scale) | Post-operative day 1 | ||
Secondary | Nausea (on a 5-point Scale) | Post-operative day 1 | ||
Secondary | Vomiting (on a 5-point Scale) | Post-operative day 1 | ||
Secondary | Side Effects (on a 5-point Scale) | Post-operative day 1 | ||
Secondary | General Satisfaction With the Procedure (on a 5-point Scale) | Post-operative day 1 |
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