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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Ketorolac; Drug: Ibuprofen

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Planned Parenthood League of Massachusetts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketorolac; 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; 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; Other Names: Toradol
Active Comparator: Ibuprofen; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Planned Parenthood League of Massachusetts
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Principal Investigator, MD, MPH, Planned Parenthood League of Massachusetts

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 19, 2011
• First Submitted That Met QC Criteria: May 8, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Estimate): July 2, 2014
• Last Update Submitted That Met QC Criteria: June 30, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: pain; suction curettage
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Ibuprofen
• Other Study ID Numbers: 2011-p-000259