NCT02642718

Brief Summary

Background: Experimental models using short duration noxious stimuli have led to the concept of pre-emptive analgesia. Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), has been shown to have a post-operative narcotic sparing effect when given pre-operatively and alternatively to not have this effect. This study was undertaken to determine whether a single intravenous dose of ketorolac would result in decreased post-operative pain and narcotic requirements. Methods: In a double-blind, randomized controlled trial, 48 women undergoing abdominal hysterectomy were studied. Patients in the ketorolac group received 30 mg of intravenous ketorolac 30 minutes before surgical incision, while the control group received normal saline. The post-operative analgesia was performed with a continuous infusion of tramadol at 12 mg/hour with the possibility of a 10 mg bolus every 10 minutes. Pain was assessed using the Visual Analog Scale (VAS), tramadol consumption and hemodynamic parameters at 0, 1, 2, 4, 8, 12, 16 and 24 hours post-operatively. We quantified times to rescue analgesic (morphine), adverse effects and patient satisfaction.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Apr 2001

Shorter than P25 for phase_4 pain

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2001

Completed
14.1 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

December 19, 2015

Last Update Submit

January 1, 2016

Conditions

Pain

Keywords

preemptive analgesiapostoperative painNSAIDsketorolacabdominal hysterectomy

Outcome Measures

Primary Outcomes (8)

  • Pain as measured by the Visual Analog Scale (VAS) score

    The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

    at 0 hours postoperatively (arrival at recovery room)

  • Pain as measured by the Visual Analog Scale (VAS) score

    The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

    at 1 hour postoperatively

  • Pain as measured by the Visual Analog Scale (VAS) score

    The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

    at 2 hours postoperatively

  • Pain as measured by the Visual Analog Scale (VAS) score

    The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

    at 4 hours postoperatively

  • Pain as measured by the Visual Analog Scale (VAS) score

    The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

    at 8 hours postoperatively

  • Pain as measured by the Visual Analog Scale (VAS) score

    The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

    at 12 hours postoperatively

  • Pain as measured by the Visual Analog Scale (VAS) score

    The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

    at 16 hours postoperatively

  • Pain as measured by the Visual Analog Scale (VAS) score

    The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

    at 24 hours postoperatively

Secondary Outcomes (1)

  • tramadol consumption

    at 0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively

Other Outcomes (8)

  • Blood Pressure (BP) systolic

    at 0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively

  • Blood Pressure (BP) diastolic

    at 0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively

  • Heart rate

    at 0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively

  • +5 more other outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

In the operating room, the anesthesiologist administered 50 mL of 0.9% saline intravenously to patients in the control group 30 minutes before surgical incision

Other: Placebo

Ketorolac Tromethamine

EXPERIMENTAL

In the operating room, the anesthesiologist administered ketorolac (30 mg) in 50 mL of 0.9 % saline intravenously to patients in the ketorolac group 30 minutes before surgical incision. (a single dose).

Drug: Ketorolac Tromethamine

Interventions

Ketorolac TromethamineDRUG

In the operating room, the anesthesiologist administered ketorolac (30 mg) in 50 mL of 0.9 % saline intravenously to patients in the ketorolac group 30 minutes before surgical incision (a single dose).

Also known as: ketorolac
Ketorolac Tromethamine
PlaceboOTHER

In the operating room, the anesthesiologist administered 50 mL of 0.9 % saline intravenously to patients in the control group 30 minutes before surgical incision

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • normal height and weight
  • ASA class I, II, III
  • elective surgery
  • surgery time between 30-150 min
  • understanding of the Visual Analog Scale (VAS)
  • no allergies or intolerance to NSAIDs or anesthetics
  • no psychiatric illness.

You may not qualify if:

  • renal deterioration
  • history of peptic ulceration
  • asthma
  • coagulopathy
  • cognitive impairment
  • inability to use the Patient Controlled Analgesia (PCA) device
  • history of chronic pain syndromes
  • history of chronic use of analgesics, sedatives, opioids or steroids
  • liver or hematologic disease
  • a history of drug or alcohol abuse
  • therapy with NSAIDs, anticoagulants, or lithium.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Complexo Hospitalario Arquitecto Marcide-Prof. Novoa Santos

Ferrol, A Coruña, 15405, Spain

Location

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

PainPain, Postoperative

Interventions

Ketorolac TromethamineKetorolac

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Beatriz Nistal-Nuño, MD

    Oxford University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist, MD

Study Record Dates

First Submitted

December 19, 2015

First Posted

December 30, 2015

Study Start

April 1, 2001

Primary Completion

October 1, 2001

Study Completion

November 1, 2001

Last Updated

January 5, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)GB(1)