PainNCT01106846
Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery
A study testing Group A: Saline Group and Group B: 1% Ketamine group in people with Pain, run by Northwestern University at 2 sites in United States.
Trial summary
Hypothesis: The intraoperative administration of ketamine will result in a 30% reduction in opiate requirement following endometrial ablation surgery and the intraoperative administration of ketamine will result in a decreased time to meet discharge criteria in the PACU following endometrial ablation surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Group A: Saline Group and Group B: 1% Ketamine group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: Female
- Age: 18-65 years
- Non-pregnant, non-lactating
- Surgery: Outpatient hysteroscopic Novasure® endometrial ablation
- Language: English speaking
- Consent: Obtained
Who cannot join
- Patient refusal
- Under 18 or over age 65
- Non-English Speaking
- Pregnancy, Breast feeding
- Hysteroscopic procedures using Thermachoice® ablation device
- Chronic use or addiction to opiates, sedatives, non-opiate analgesics
Show all 12Show fewer
- History of heavy alcohol usage (>4 drinks/day)
- Significant cardiovascular or pulmonary disease
- Psychiatric or emotional disorder
- Allergy to anesthetic agents utilized in the protocol
- Glaucoma
- Thyrotoxicosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
Prentice Women's Hosptial
Chicago, Illinois, 60611
About this study
Hypothesis: The intraoperative administration of ketamine will result in a 30% reduction in opiate requirement following endometrial ablation surgery and the intraoperative administration of ketamine will result in a decreased time to meet discharge criteria in the PACU following endometrial ablation surgery.
The research question is "Does intraoperative administration of ketamine result in decreased postoperative opiate requirement and time to discharge from the postanesthesia recovery unit (PACU) following hysteroscopic endometrial ablation".
Read the detailed description
Preoperatively:
Subjects will be recruited up to 21days prior to the day of surgery. After informed consent is obtained, subjects will be randomly assigned to one of two groups:
Group A: Saline group Group B: 1% Ketamine group
A verbal rating scale (VRS) will be used to assess pain preoperatively. The patient will be asked to identify the severity of pain by indicating on a scale of 0-10 where 0 is "no pain" and 10 is "the worst pain imaginable".
Baseline Quality of Recovery will be obtained. (Appendix F)
Subjects will be randomized prior to surgery to either Group A or Group B. The randomization table is computer generated. There is a 50% allocation to each group.
Intraoperatively:
Standard anesthetic monitoring will be used including monitoring of processed EEG including either the bi-spectral index (BIS) or similar standard of care ASA monitor. A standardized intraoperative anesthetic plan will be utilized by the anesthesia personnel. (Appendix A). Study drug will be prepared and labeled in 10mL syringes by research personnel who will not be involved in the study assessments. Study drug will be administered on initial insertion of Novasure® device (Appendix B).
Postoperatively:
Pain scores in the PACU will be assessed using the VRS upon admission and every 30 minutes thereafter until discharge criteria are met.
Additionally, nausea, vomiting and retching episodes will be recorded using a VRS.
Postoperative analgesic and antiemetic therapy will be standardized and total amounts of these agents will be recorded Assessment of psychomimetic effects including sedation and agitation will be assess postoperatively prior to discharge using the Richmond Agitation/Sedation Scale (Appendix D).
Acute recovery will be assessed using the Modified Post Anesthesia Discharge Scoring System (MPADSS) (Appendix E). A score of 8 or greater will indicate discharge readiness. Time to fulfill discharge criteria will be recorded.
Any other adverse events and medications required will be recorded. These data will be recorded by research personnel who will be blinded to the study group assignments.
Subjects will be contacted by telephone 24 hours after surgery to assess post-discharge quality of recovery (Appendix F).
- Conditions
- Pain
- Being tested
- Group A: Saline Group, Group B: 1% Ketamine group
- Keywords
- Ketamine, Anesthesia, Pain, Outpatient surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: Saline GroupDrug
Also called Saline
Saline continuous infusion
Group B: 1% Ketamine groupDrug
Also called Ketamine
Administration of 1% ketamine intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Saline group | Placebo comparator | Group A: Saline group , infusion of saline intravenously Receives: Drug: Group A: Saline Group |
| Group B: 1% Ketamine group | Active comparator | Group B: Infusion of ketamine 1% intravenously Receives: Drug: Group B: 1% Ketamine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery Score Post Operative at 24 Hours
Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery.
Measured: 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Resources not available to complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shireen Ahmad, Northwestern University
- Investigators
- Shireen Ahmad, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106846
- Sponsor's protocol ID
- STU00026695
- Status last verified
- Jul 2015
- First submitted
- 16 Apr 2010
- Last updated
- 7 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schenker JG, Margalioth EJ. Intrauterine adhesions: an updated appraisal. Fertil Steril. 1982 May;37(5):593-610. doi: 10.1016/s0015-0282(16)46268-0. No abstract available.
PubMed 6281085Jansen FW, Vredevoogd CB, van Ulzen K, Hermans J, Trimbos JB, Trimbos-Kemper TC. Complications of hysteroscopy: a prospective, multicenter study. Obstet Gynecol. 2000 Aug;96(2):266-70. doi: 10.1016/s0029-7844(00)00865-6.
PubMed 10908775Wong AY, Wong K, Tang LC. Stepwise pain score analysis of the effect of local lignocaine on outpatient hysteroscopy: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2000 Jun;73(6):1234-7. doi: 10.1016/s0015-0282(00)00498-2.
PubMed 10856489Lau WC, Ho RY, Tsang MK, Yuen PM. Patient's acceptance of outpatient hysteroscopy. Gynecol Obstet Invest. 1999;47(3):191-3. doi: 10.1159/000010092.
PubMed 10087415De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.
PubMed 10648742MacPherson RD, Woods D, Penfold J. Ketamine and midazolam delivered by patient-controlled analgesia in relieving pain associated with burns dressings. Clin J Pain. 2008 Sep;24(7):568-71. doi: 10.1097/AJP.0b013e31816cdb20.
PubMed 18716494White PF, Way WL, Trevor AJ. Ketamine--its pharmacology and therapeutic uses. Anesthesiology. 1982 Feb;56(2):119-36. doi: 10.1097/00000542-198202000-00007. No abstract available.
PubMed 6892475Bowdle TA, Radant AD, Cowley DS, Kharasch ED, Strassman RJ, Roy-Byrne PP. Psychedelic effects of ketamine in healthy volunteers: relationship to steady-state plasma concentrations. Anesthesiology. 1998 Jan;88(1):82-8. doi: 10.1097/00000542-199801000-00015.
PubMed 9447860Deng XM, Xiao WJ, Luo MP, Tang GZ, Xu KL. The use of midazolam and small-dose ketamine for sedation and analgesia during local anesthesia. Anesth Analg. 2001 Nov;93(5):1174-7. doi: 10.1097/00000539-200111000-00023.
PubMed 11682390
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery
- ClinicalTrials.gov ID
- NCT01106846
- Acronym / sponsor ID
- STU00026695
- Conditions
- Pain
- Keywords
- Ketamine, Anesthesia, Pain, Outpatient surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resources not available to complete.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Posted 20 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: The intraoperative administration of ketamine will result in a 30% reduction in opiate requirement following endometrial ablation surgery and the intraoperative administration of ketamine will result in a decreased time to meet discharge criteria in the PACU following endometrial ablation surgery.
The research question is "Does intraoperative administration of ketamine result in decreased postoperative opiate requirement and time to discharge from the postanesthesia recovery unit (PACU) following hysteroscopic endometrial ablation".
Detailed description
Preoperatively:
Subjects will be recruited up to 21days prior to the day of surgery. After informed consent is obtained, subjects will be randomly assigned to one of two groups:
Group A: Saline group Group B: 1% Ketamine group
A verbal rating scale (VRS) will be used to assess pain preoperatively. The patient will be asked to identify the severity of pain by indicating on a scale of 0-10 where 0 is "no pain" and 10 is "the worst pain imaginable".
Baseline Quality of Recovery will be obtained. (Appendix F)
Subjects will be randomized prior to surgery to either Group A or Group B. The randomization table is computer generated. There is a 50% allocation to each group.
Intraoperatively:
Standard anesthetic monitoring will be used including monitoring of processed EEG including either the bi-spectral index (BIS) or similar standard of care ASA monitor. A standardized intraoperative anesthetic plan will be utilized by the anesthesia personnel. (Appendix A). Study drug will be prepared and labeled in 10mL syringes by research personnel who will not be involved in the study assessments. Study drug will be administered on initial insertion of Novasure® device (Appendix B).
Postoperatively:
Pain scores in the PACU will be assessed using the VRS upon admission and every 30 minutes thereafter until discharge criteria are met.
Additionally, nausea, vomiting and retching episodes will be recorded using a VRS.
Postoperative analgesic and antiemetic therapy will be standardized and total amounts of these agents will be recorded Assessment of psychomimetic effects including sedation and agitation will be assess postoperatively prior to discharge using the Richmond Agitation/Sedation Scale (Appendix D).
Acute recovery will be assessed using the Modified Post Anesthesia Discharge Scoring System (MPADSS) (Appendix E). A score of 8 or greater will indicate discharge readiness. Time to fulfill discharge criteria will be recorded.
Any other adverse events and medications required will be recorded. These data will be recorded by research personnel who will be blinded to the study group assignments.
Subjects will be contacted by telephone 24 hours after surgery to assess post-discharge quality of recovery (Appendix F).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Saline group | Placebo comparator | Drug: Group A: Saline GroupGroup A: Saline group , infusion of saline intravenously |
| Group B: 1% Ketamine group | Active comparator | Drug: Group B: 1% Ketamine groupGroup B: Infusion of ketamine 1% intravenously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Gender: Female
- Age: 18-65 years
- Non-pregnant, non-lactating
- Surgery: Outpatient hysteroscopic Novasure® endometrial ablation
- Language: English speaking
Key exclusion criteria (12 listed)
- Patient refusal
- Under 18 or over age 65
- Non-English Speaking
- Pregnancy, Breast feeding
- Hysteroscopic procedures using Thermachoice® ablation device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A: Saline GroupAlso: SalineSaline continuous infusion | Drug | Group A: Saline group |
| Group B: 1% Ketamine groupAlso: KetamineAdministration of 1% ketamine intravenously. | Drug | Group B: 1% Ketamine group |
Primary outcome
Quality of Recovery Score Post Operative at 24 Hours
Time frame: 24 hours post operative
Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 6281085Schenker JG, Margalioth EJ. Intrauterine adhesions: an updated appraisal. Fertil Steril. 1982 May;37(5):593-610. doi: 10.1016/s0015-0282(16)46268-0. No abstract available.
- Background: PubMed 10908775Jansen FW, Vredevoogd CB, van Ulzen K, Hermans J, Trimbos JB, Trimbos-Kemper TC. Complications of hysteroscopy: a prospective, multicenter study. Obstet Gynecol. 2000 Aug;96(2):266-70. doi: 10.1016/s0029-7844(00)00865-6.
- Background: PubMed 10856489Wong AY, Wong K, Tang LC. Stepwise pain score analysis of the effect of local lignocaine on outpatient hysteroscopy: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2000 Jun;73(6):1234-7. doi: 10.1016/s0015-0282(00)00498-2.
- Background: PubMed 10087415Lau WC, Ho RY, Tsang MK, Yuen PM. Patient's acceptance of outpatient hysteroscopy. Gynecol Obstet Invest. 1999;47(3):191-3. doi: 10.1159/000010092.
- Background: PubMed 10648742De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.
- Background: PubMed 18716494MacPherson RD, Woods D, Penfold J. Ketamine and midazolam delivered by patient-controlled analgesia in relieving pain associated with burns dressings. Clin J Pain. 2008 Sep;24(7):568-71. doi: 10.1097/AJP.0b013e31816cdb20.
- Background: PubMed 6892475White PF, Way WL, Trevor AJ. Ketamine--its pharmacology and therapeutic uses. Anesthesiology. 1982 Feb;56(2):119-36. doi: 10.1097/00000542-198202000-00007. No abstract available.
- Background: PubMed 9447860Bowdle TA, Radant AD, Cowley DS, Kharasch ED, Strassman RJ, Roy-Byrne PP. Psychedelic effects of ketamine in healthy volunteers: relationship to steady-state plasma concentrations. Anesthesiology. 1998 Jan;88(1):82-8. doi: 10.1097/00000542-199801000-00015.
- Background: PubMed 11682390Deng XM, Xiao WJ, Luo MP, Tang GZ, Xu KL. The use of midazolam and small-dose ketamine for sedation and analgesia during local anesthesia. Anesth Analg. 2001 Nov;93(5):1174-7. doi: 10.1097/00000539-200111000-00023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shireen Ahmad, MD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: Saline Group and Group B: 1% Ketamine group in people with Pain, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery Score Post Operative at 24 Hours (time frame: 24 hours post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01106846, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.