Oral Sedation During Cervical Dilator Placement

Oral Sedation and Cervical Dilator Pain Clinical Trial

— OSDI  

Official title:

Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202550
• Other study ID #: IRB00117627
• Status: Completed
• Phase: Phase 4
• Start date: June 28, 2017
• Est. completion date: May 28, 2019

Study information

• Verified date: March 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a randomized, double-blind, placebo-controlled trial involving 2 arms. It will be comparing the effects of placebo compared to 1 mg oral lorazepam/5 mg oral oxycodone on pain scores during cervical dilator placement prior to dilation and evacuation (D&E).

Description:

Potential participants will be first introduced to the study via routine intake call. Participants will be identified at the participant's office visits to the Johns Hopkins' Women's Center for Family Planning. If a patient desires D&E for a second trimester pregnancy, the patient will first receive standard counseling. Only after providing written informed consent for the procedure will the patients be screened for eligibility in the study. If the patient is eligible the participant will be asked by a member of the research team if the patient is interested in participating. If the patient is, the study will be explained to the participant and written consent will be obtained after participant is given the opportunity to have all questions answered.

The study is randomized, double-blind, placebo-controlled trial involving 2 arms. Participants will first complete a survey to collect demographic data.

Participants in both arms will receive the institution's current standard analgesia for cervical dilator placement. In addition to this standard regimen, participants will be randomized to receive either: (1) a dose of two oral placebo pills, or (2) 1mg of oral lorazepam with 5 mg of oral oxycodone prior to cervical dilator placement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 28, 2019
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women aged 18-50 years

• English speaking

• With an intrauterine pregnancy (either viable or non-viable) between the gestational ages of 17w0d and 23w6d

• Have a support person present with participant

• Have a cell phone capable of text messaging (optional)

Exclusion Criteria:

• Non-English-speaking

• Taking a daily benzodiazepine or opiate

• Have a known allergy or contraindication to NSAIDs, opiates, or benzodiazepines

Related Conditions & MeSH terms

• Oral Sedation and Cervical Dilator Pain

Intervention

Drug:
• Oxycodone and Lorazepam (Active Comparator)
Oxycodone and Lorazepam
• Placebo Comparator
Placebo oral pills

Locations

Country	Name	City	State
United States	Johns Hopkins' Women's Center for Family Planning	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Society of Family Planning

Country where clinical trial is conducted

United States, 

References & Publications (4)

Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23. — View Citation

Soon, R. T., M.; Salcedo. J.; Kaneshiro, B., Paracervical block to decrease pain with second-trimester laminaria insertion: a randomized controlled trial. Contraception 2016, 94 (4), 389.

Wiebe E, Podhradsky L, Dijak V. The effect of lorazepam on pain and anxiety in abortion. Contraception. 2003 Mar;67(3):219-21. — View Citation

Wong CY, Ng EH, Ngai SW, Ho PC. A randomized, double blind, placebo-controlled study to investigate the use of conscious sedation in conjunction with paracervical block for reducing pain in termination of first trimester pregnancy by suction evacuation. Hum Reprod. 2002 May;17(5):1222-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)	Immediately after the last dilator is placed, up to 1 minute
Secondary	Number of Participants With Desired Number of Dilators Inserted	Assess whether desired number of dilators was not able to be successfully inserted, comparing 2 arms.	After speculum removed, up to 30 minutes
Secondary	Baseline Pain Score Before Drugs Were Administered	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)	pain score given prior to administration of study drugs, up to 1 minute
Secondary	Pain Score Before Speculum Placement	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)	pain score given before specula placed, up to 1 minute
Secondary	Pain Score After Speculum Placement	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)	pain score given at time of speculum placement, up to 1 minute
Secondary	Pain Score at Tenaculum Placement	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)	Immediately scored at time of tenacula placement, up to 1 minute
Secondary	Pain Score During Paracervical Block	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)	pain score given at time of paracervical block administration, up to 1 minute
Secondary	Pain Score After First Dilator Placement	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)	pain score given immediately after first dilator placed, up to 1 minute
Secondary	Pain Score 15 Minutes After Last Dilator Placed	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever). This was to be assessed at 15 minutes after last dilator is placed. Some participants had this assessment done up to 45 minutes after last dilator was placed because it could not be done at 15 minutes (some were being attended to by a nurse at the 15 minutes mark).	Assessed up to 45 minutes after last dilator placed