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Trial record 29 of 415 for:    KETOROLAC

Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery

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ClinicalTrials.gov Identifier: NCT02729285
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : September 22, 2016
Sponsor:
Information provided by (Responsible Party):
Lin Lu, Sun Yat-sen University

Brief Summary:
The scleral buckle surgery is an effective way in treating retinal detachment (RD) patients. Retrobulbar block has been proved effective in scleral buckle surgery. Though retrobulbar anesthesia saves operative time and money compared to general analgesia, the intraoperative pain is frequent and a proportion of postoperative pain is often ignored. Ketorolac has been demonstrated to be a preemptive analgesia in other diseases such as adenotonsillectomy, posterior lumbar spinal fusion, laser-assisted subepithelial keratectomy (LASEK), and so forth. The aim of the investigators study is to determine the safety and preemptive analgesic effect of ketorolac in the perioperative pain control of patients undergoing RD surgery under retrobulbar anesthesia.

Condition or disease Intervention/treatment Phase
Pain Drug: Ketorolac Tromethamine Drug: placebo Procedure: scleral buckle Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Preoperative Ketorolac for Intraoperative and Postoperative Pain Management in Scleral Buckling Surgery Under Retrobulbar Block Anesthesia: A Prospective, Randomized, Controlled Study
Study Start Date : July 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketorolac Tromethamine
On operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 minutes before scleral buckle surgery.
Drug: Ketorolac Tromethamine
On operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 min before scleral buckle surgery.
Other Name: ketorolac

Procedure: scleral buckle
Surgical procedure of scleral buckle under retrobulbar block anesthesia

Placebo Comparator: placebo
On operation day, the patients were randomly assigned to receive placebo before scleral buckle surgery.
Drug: placebo
On operation day, the patients were randomly assigned to receive placebo 30 min before scleral buckle surgery.
Other Name: disambiguation

Procedure: scleral buckle
Surgical procedure of scleral buckle under retrobulbar block anesthesia




Primary Outcome Measures :
  1. Pain score using numerical rating scale (NRS) [ Time Frame: preoperative ]
  2. Pain score using numerical rating scale (NRS) [ Time Frame: intraoperative ]
    any pain during the whole operation time

  3. Pain score using numerical rating scale (NRS) [ Time Frame: immediately after operation ]
  4. Pain score using numerical rating scale (NRS) [ Time Frame: at 4 hours postoperatively ]
  5. Pain score using numerical rating scale (NRS) [ Time Frame: at 24 hours postoperatively ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. consent of the patient or legal guardian
  2. 18 years or above
  3. normal height and weight
  4. ASA class I, II
  5. elective surgery
  6. surgery time within 60min
  7. understanding of the verbal numerical rating score (0-10)

Exclusion Criteria:

  1. history of ocular surgery, trauma or infection
  2. intraoperative complications
  3. glaucoma or ocular hypertension (> 20 mmHg)
  4. diabetic retinopathy
  5. diagnosis of asthma or coagulopathy
  6. chronic pain syndromes
  7. history of peptic ulceration, liver or hematologic disease
  8. history of chronic use of analgesics, sedatives, opioids or steroids
  9. history of drug or alcohol abuse
  10. history of systemic disease
  11. sexually transmitted disease (STD)
  12. Pregnancy, lactation;
  13. cognitive impairment or psychiatric illness;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729285


Locations
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Lu Lin Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lin Lu, Director, Fundus Disease Center of Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02729285     History of Changes
Other Study ID Numbers: 2014MEKY042
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action