Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage

Pain Clinical Trial

Official title:

Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage: a Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595282
• Other study ID #: 2011-p-000259
• Status: Completed
• Phase: N/A
• First received: May 19, 2011
• Last updated: June 30, 2014
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2014
• Source: Planned Parenthood League of Massachusetts
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the effect of pre-procedural ketorolac to ibuprofen on immediate post-procedural pain scores in patients undergoing first trimester suction curettage with local anesthesia only.

Our primary hypothesis is that IM ketorolac compared to oral ibuprofen will result in an approximate 30% reduction in pain scores on a 21-point numerical rating scale immediately after the procedure.

Secondary hypotheses include:

• Pain scores on the 21-point scale will also be significantly lower in the ketorolac group immediately after cervical dilation and 15 minutes post-procedure.

• Fewer patients in the ketorolac group will rate their pain as "severe" on a subjective pain rating scale.

• Patients in the ketorolac group will be more satisfied with their pain control.

• Side effects will be similar between groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women age 18 or older seeking suction curettage at Planned Parenthood League of Massachusetts (PPLM)

• Gestational age less than or equal to 11+6, confirmed by ultrasound

• Eligible for suction curettage according to PPLM protocols

• Choice of local anesthesia

Exclusion Criteria:

• Choice of IV sedation for pain control

• Hypersensitivity to NSAIDs or lidocaine

• Contraindications to NSAIDs:

Active renal disease Active hepatic disease Gastric ulcer disease or gastritis Long-term NSAID or aspirin use Bleeding disorder

• NSAIDs taken < 8 hours prior to procedure

• Need for cervical ripening with either misoprostol or mechanical priming agent (laminaria/Dilapan)

• Long-term narcotic use

• Unable or unwilling to complete required study procedures

• Previous participation in the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ketorolac
For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure
• Ibuprofen
For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure.

Locations

Country	Name	City	State
United States	Planned Parenthood League of Massachusetts	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Planned Parenthood League of Massachusetts	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate Post-procedure Pain Score	The primary endpoint is subjects' immediate post-procedure pain score on a 21-point 0 to 100 scale, 0 = no pain and 100 = worst possible pain (in increments of five). This scale has been previously validated and used for research purposes, including for pain research evaluating suction curettage elsewhere and at our institution (Jensen 1986, Williamson 2004, Allen 2009).	Immediately (within 1 minute) after suction and speculum removal	No
Secondary	Pain Scores Immediately After Cervical Dilation	21-point 0 to 100 scale where 0 = no pain and 100 = worst possible pain (in increments of five)	Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula	No
Secondary	Pain Scores 15 Minutes Post-procedure	21-point 0 to 100 scale, where 0 = no pain and 100 = worst possible pain (in increments of five)	Fifteen minutes after the procedure	No