N/A N=200 Randomized Triple-blind Supportive Care

Intracervical Lidocaine Gel for IUD Insertional Pain

Pain

Bottom Line

View on ClinicalTrials.gov: NCT01214161 ↗

Enrolled (actual)

200

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcome: Primary: Pain During IUD Insertion at Various Time Points (See Description for Time Points) — 35.4; 34.3; 55.5; 51.6 units on a 100 mm visual analogue scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 2% lidocaine gel (Drug); placebo (Other)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Columbia University
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain During IUD Insertion at Various Time Points (See Description for Time Points)	35.4; 34.3; 55.5; 51.6; 51.0; 50.9	—
SECONDARY Adverse Events	8; 4; 0; 0; 9; 12	—
SECONDARY Provider's Assessment of Patient's Maximum Pain on a Visual Analogue Scale	63.8; 35.3	—

Summary

The intrauterine device (IUD) is a form of birth control that is extremely effective and safe, even in women who have not yet had children. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method. This study will randomly (like flipping a coin) assign women who have chosen the IUD as their contraceptive into two groups. One group will have lidocaine anesthetic gel placed into their cervix prior to having the IUD inserted; the other will have an inert gel placed into their cervix instead. The level of pain at three different time points on a 10cm scale and the patient's satisfaction with the procedure will be compared between the two groups to see if using lidocaine gel helps decrease IUD insertional pain

Eligibility Criteria

Inclusion Criteria

Self-select either a Paragard or Mirena IUD and are appropriate for insertion as determined by their provider
Age 18-45
Speak English or Spanish

Exclusion Criteria

Lidocaine allergy
First trimester abortion or miscarriage in the previous six weeks
Second trimester abortion or miscarriage in the previous 12 weeks

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01214161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.