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

NCT01595282 | Completed Results

• 1 other identifier: 2011-p-000259
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

pain; suction curettage

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Pain Scores Immediately After Cervical Dilation

  Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula

• Pain Scores 15 Minutes Post-procedure

  Fifteen minutes after the procedure

Study Arms (2)

Ketorolac

EXPERIMENTAL

Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)

Drug: Ketorolac

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo

Drug: Ibuprofen

Interventions

Ketorolac DRUG

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

Also known as: Toradol

Ketorolac

Ibuprofen DRUG

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.

Ibuprofen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Planned Parenthood League of Massachusetts: lead
• Society of Family Planning: collaborator

Study Sites (1)

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Ketorolac; Ketorolac Tromethamine; Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Principal Investigator
• Organization: PPLM

617-616-1600

Study Officials

• Principal Investigator, MD, MPH

  Planned Parenthood League of Massachusetts

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 10, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 2, 2014
• Results First Posted: July 2, 2014

Record last verified: 2014-06

Locations

US (1)