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

Planned Parenthood League of Massachusetts

Status: Completed

Conditions: Pain

Treatments: Drug: Ibuprofen; Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT01595282

2011-p-000259

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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94 participants in 2 patient groups

Ketorolac

Experimental group

Description:

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)

Treatment:

Drug: Ketorolac

Ibuprofen

Active Comparator group

Description:

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

Treatment:

Drug: Ibuprofen